Clinical Research & Trials

4AP/ UGUP18139/ Ahmed Ghazi

Lead Researcher: Ahmed Ghazi

To evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral nerve traction and/or crush injury. This study aims to test the hypothesis that 4-aminopyridine speeds the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.

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A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)

This is a global, randomized, double-blind, controlled study to evaluate the efficacy of bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2 selected Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA blood assay demonstrating FGFR2 gene amplification)

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A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies

Lead Researcher: Nimish Mohile

This is a dose-escalation study of DSP-7888 Dosing Emulsion administered to adult patients with advanced malignancies. Patients will be administered escalating doses of DSP-7888 Dosing Emulsion intradermally (between the skin layers) or subcutaneously (under the skin) in accordance with the following regimen: once weekly for four weeks during the Induction Phase, once every 7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days until a discontinuation criterion is met during the Maintenance Phase. Once the highest dose with acceptable toxicity is determined from either the intradermal or subcutaneous group, an additional 40 patients may be enrolled as an expansion cohort at this dose and route of administration to confirm safety and tolerability. Separate from the dose-ascending cohort and expansion cohort described previously, and once the intradermal dose-ascending cohort is completed, up to 20 myelodysplastic syndrome (MDS) patients who are resistant to treatment with hypomethylating agents (HMAs) will be enrolled into an MDS expansion cohort. Of these 20 MDS patients, one-half will receive DSP-7888 at 10.5 mg according to the modified schedule employed in Phase 1 (every week for 4 weeks, every 2 weeks until Week 24, and then every 4 weeks [Named MDS Cohort 1]). The other half of the MDS patients will receive DSP-7888 at 10.5 mg in an alternative dosing schedule where DSP-7888 is administered every 2 weeks until Week 24, after which it will be administered every 4 weeks (Named MDS Cohort 2).

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A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Lead Researcher: Lawrence Saubermann

The purpose of this program is to evaluate the efficacy and safety of guselkumab (an injection under the skin) in participants with Crohn's disease. Inclusion Criteria: Have Crohn's disease or fistulizing Crohn's disease for at least 3 months duration (a minimum of 12 weeks). Have demonstrated intolerance or inadequate response to conventional or biologic therapy for Chrohn's disease.

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A Study to Evaluate the Efficacy and Safety of RO7105705 in Patients With Prodromal to Mild Alzheimer's Disease

This is a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of RO7105705 in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period will be available to participants who complete the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label RO7105705 treatment.

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A041703 / CLEU19006 / O'Dwyer, Kristen

Lead Researcher: Kristen O'Dwyer

This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back, or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

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ALCHEMIST A151216 Screening Protocol

Lead Researcher: Yuhchyau Chen

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

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Assessment of Patients with Brain Tumors, Ages 65+

Lead Researcher: Andrea Wasilewski

The purpose of this study is to collect information about the physical function, thinking, independence, social support, and medications of older patients with brain tumors in order to develop more specialized treatments and support for that population. Inclusion Criteria: Age 65 or older of any race, ethnicity, or gender; Pathologically confirmed glioblastoma or anaplastic astrocytoma; Have not started radiation or chemotherapy for brain tumor treatment

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Baby formula and health

Lead Researcher: Bridget Young

Participation in this study involves one visit that will last for about four hours at your home or the Strong Memorial Hospital Clinical Research Center. Procedures include infant glucose test, timed infant urine collection, infant heel pricks, and infant body size measurements.

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Cancer (Geriatric): Cognitive Rehabilitation For At-Risk Older Cancer Patients Receiving Chemotherapy: A Pilot Study Evaluating Feasibility And Impact

Lead Researcher: Allison Shifflet

In Phase I all subjects will receive cognitive rehabilitation intervention which includes, workshops and at-home computer-based cognitive training. In the phase II portion of the study, depending on the group you are assigned, you may receive cognitive rehabilitation intervention or usual care. This will help researchers develop a doable approach to cognitive rehabilitation and see if it helps reduce the risk of developing progressive cognitive impairments which is a common side effect of chemotherapy.

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Cancer: Geriatric Assessment and Clinical Outcomes in Older Oncology Patients (SOCARE)

Lead Researcher: Supriya Mohile

We are asking for your participation in this study not as consent to undergo this testing (as it is undertaken for all new patients), but so that we may follow your evaluation results, and determine how this testing influences our shared decisions regarding your care and treatment. This information is useful, as it is understood that older patients (greater than or equal to 65-years old) often have different levels of health, and outside challenges that can influence their care. Historically, older patients have not received equal treatment for cancer and may be at greater risk for possible side effects from treatment. It is our hope that these tools, well-established at identifying areas of risk, will provide meaningful opportunities of intervention that will promote your safety.

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CBMT11074 / NMDP 10-CBA / Jane Liesveld

Lead Researcher: Jane Liesveld

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

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CBRS18119 / S1706 / Ajay Dhakal

Lead Researcher: Ajay Dhakal

This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.

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CBRS19033 / TMIST / Avice O'Connell

Lead Researcher: Avice O'Connell

This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

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CBRS19096 / A221702 / Kristin Skinner

Lead Researcher: Kristin Skinner

This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.

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CBRS20023, Dhakal, EA1181, Breast Cancer, Paclitaxel Docetaxel Trastuzumab Pertuzumab Nab-paclitaxel

Lead Researcher: Ajay Dhakal

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.

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CBRS20072 / A011202 / Skinner

Lead Researcher: Kristin Skinner

This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.

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CBRS20109 / EAZ171 / Alissa Huston

Lead Researcher: Alissa Huston

This phase II trial studies how well docetaxel or paclitaxel work in reducing chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer. Drugs used in chemotherapy, such as docetaxel and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving docetaxel or paclitaxel may work better than other methods in reducing chemotherapy-induced peripheral neuropathy in patients with breast cancer.

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CBRS21001 / A011801 / Dhakal

Lead Researcher: Ajay Dhakal

This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

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CBRT20074 / A071701 / Michael White

Lead Researcher: Michael White

This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these genes such as abemaciclib, paxalisib, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.

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CBRT20102 / NRG-BN007 / Andrea Wasilewski

Lead Researcher: Andrea Wasilewski

This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy in combination with immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons to kill tumor and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temozolomide, may not work as well for the treatment of tumors that have the unmethylated MGMT. Immunotherapy with monoclonal antibodies called immune checkpoint inhibitors, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is possible that immune checkpoint inhibitors may work better at time of first diagnosis as opposed to when tumor comes back. Giving radiation therapy with ipilimumab and nivolumab may lengthen the time without brain tumor returning or growing and may extend patients' life compared to usual treatment with radiation therapy and temozolomide.

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Cervical Cancer/ Emergency Department/ UCCS20125/ David Adler

Lead Researcher: David Adler

Invasive cervical cancer is preventable with adequate screening but screening rates are considerably below national goals. Emergency departments care for a disproportionate number of women who are not up to date with recommended cervical cancer screening. This study will evaluate the effectiveness of a mobile technology based behavioral intervention (using text messaging prompts) to increase cervical cancer screening uptake among emergency department patients.

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CGIM20007, Hezel, S1922, Small Intestinal Adenocarcinoma, Fluorouracil, Irinotecan Hydrochloride

Lead Researcher: Aram Hezel

This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This may restrain new blood vessel formation therefore reducing nutrient supply to tumor which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy, such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Ramucirumab plus paclitaxel or FOLFIRI, may be helpful in treating advanced or refractory small bowel cancers and may help patients live longer.

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CGIP19127 / A021602 / Aram Hezel

Lead Researcher: Aram Hezel

This randomized phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that have spread to other places in the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

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CGIP20076, Zittel, EA2186, 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan

Lead Researcher: Jason Zittel

This phase II trial compares two treatment combinations: gemcitabine hydrochloride and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan in older patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine hydrochloride, nab-paclitaxel, fluorouracil, leucovorin calcium, and liposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help doctors find out which treatment combination is better at prolonging life in older patients with metastatic pancreatic cancer.

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CGIP20087 / A021806 / Richard Dunne

Lead Researcher: Richard Dunne

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

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CGUB19067 / S1600 / Edward Messing

Lead Researcher: Edward Messing

This phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.

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CGUK20101 / A031704 / Deepak Sahasrabudhe

Lead Researcher: Deepak Sahasrabudhe

This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.

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CGUK20147 / S1931 / Frye

Lead Researcher: Thomas Frye

This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.

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CGUP18150 / S1802 / Chunkit Fung

Lead Researcher: Chunkit Fung

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

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CGYC16057 / NRG-GY006 / Richard Moore

Lead Researcher: Richard Moore

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

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CGYE19140 / NRG-GY018 / Richard Moore

Lead Researcher: Richard Moore

This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.

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CGYE21013 / NRG-GY020 / Richard Moore

Lead Researcher: Richard Moore

This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.

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CGYM19142 / NRG-GY019 / Richard Moore

Lead Researcher: Richard Moore

This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.

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CGYN18151 / NRG-GY012 / Richard Moore

Lead Researcher: Richard Moore

This phase II trial studies the effects of the combination of olaparib and durvalumab, cediranib and durvalumab, olaparib and capivasertib, and cediranib alone in treating patients with endometrial cancer that has come back (recurrent) or does not respond to treatment (refractory). Olaparib, cediranib, and capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Testing the combinations may lower the chance of endometrial cancer growing or spreading compared to usual care.

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CGYO20085 / NRG-CC008 / Richard Moore

Lead Researcher: Richard Moore

This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.

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Challenges associated with vision loss

Lead Researcher: Steven Silverstein

You will be asked to complete 3 surveys online that will take about a total of 25-30 minutes to complete. The surveys will ask questions about how you have adjusted to your vision loss, as well as the effects of vision loss on your mood, anxiety, and quality of life.

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CHAN19107 / EA3161 / Megan Baumgart

Lead Researcher: Megan Baumgart

This phase III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer (throat cancer) that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.

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CHAN19131 / NRG-HN005 / Singh

Lead Researcher: Deepinder Singh

This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.

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Chronic Pain Study

Lead Researcher: Paul Geha

This study will use subjective rating methods, computer-based games, and brain imaging to study the characteristics of chronic pain and brain processes that cause them. By so doing we hope to obtain new information and understanding of chronic pain across multiple conditions. Eligibility: Ages 18-65; in generally stable health; diagnosed with a pain condition: Chronic back pain (CBP), Osteoarthritis of the knee (OAk), Temporomandibular joint disorder(TMJ), Complex regional pain syndrome (CRPS), or Pelvic Pain (PP).

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CLEU18093 / A041501 / Kristen O'Dwyer

Lead Researcher: Kristen O'Dwyer

This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

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CLEU19025 / A041701 / Chemo + Uproleselan for AML / Jane Liesveld

Lead Researcher: Jane Liesveld

This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.

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CLEU20105/ S1905/ Kristen O'Dwyer

Lead Researcher: Kristen O'Dwyer

This phase II trial studies how well OBI-3424 works in treating patients with T-cell acute lymphoblastic leukemia that has come back (relapsed) or does not response to treatment (refractory). Drugs used in chemotherapy, such as OBI-3424, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. OBI-3424 may reduce the amount of leukemia in the body.

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CLEU20136 / EA9181 / O'Dwyer

Lead Researcher: Kristen O'Dwyer

This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

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CLUN19026 / LUNGMAP / Megan Baumgart

Lead Researcher: Megan Baumgart

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

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CLUN20055 / EA5181 / Arpan Patel, MD

Lead Researcher: Arpan Patel

This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.

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CLYM17097 / S1608 / Paul Barr

Lead Researcher: Paul Barr

This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.

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CLYM17103 / EA4151 / Paul Barr

Lead Researcher: Paul Barr

This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.

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CLYM19112 / S1826 / Jonathan Friedberg

Lead Researcher: Jonathan Friedberg

This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.

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CLYM19123 / AALL1731 / Angela Girvin

Lead Researcher: Angela Girvin

This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better than combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.

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CLYM19150 / EA4181 / Reagan

Lead Researcher: Patrick Reagan

This phase II trial compares three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib and studies how well they work in treating patients with newly diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This study is being done to find out if one the drug combinations of bendamustine, rituximab, high dose cytarabine, and acalabrutinib is better or worse than the usual approach for mantle cell lymphoma.

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CLYM20151 / S1925 / Barr

Lead Researcher: Paul Barr

This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

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CMEL19154, Adrienne Victor, S1801, Melanoma, Pemrolizumab

Lead Researcher: Adrienne Victor

This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.

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CMEL20008, Victor, EA6174, Merkel Cell Carcinoma, Pembrolizumab

Lead Researcher: Adrienne Victor

This phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery (resected). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

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CMLT20100 / S1823 / Chunkit Fung

Lead Researcher: Chunkit Fung

This trial studies whether the blood marker micro ribonucleic acid (miRNA) 371 can predict the chance of cancer returning in patients with germ cell cancers. Studying samples of blood from patients with germ cell cancers in the laboratory may help doctors predict how likely the cancer will come back.

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CMMY19113 / S1803 / Brea Lipe

Lead Researcher: Brea Lipe

Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.

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Comparing Healthy Young Adults/Children to Those With CLN3 Disease

Lead Researcher: Erika Augustine

We are inviting children and young adults with no known neurological disease to participate in a research study that involves brain magnetic resonance imaging (MRI) scans over three years. The purpose of this study is to prepare for future clinical trials focused on a rare disease called CLN3 disease. CLN3 disease is a neurodegenerative disease affecting children and young adults. As part of this study, we are examining the ways in which CLN3 disease affects the brain. To understand this impact, we will use MRI scans to compare the brains of healthy people to brains of people with CLN3 disease. Following the initial study visit, visits will take place at 6, 12, 18, 24, and 36 months. Compensation will be provided following each completed study visit.

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COVID-19 Vaccine Studies

Lead Researcher: Ann Falsey

URMC is studying several variations of a COVID-19 vaccine. Compensation: $500-$900. Participation Requirements: Age 18+; Have not been infected with COVID-19. To volunteer, take our survey to find out if you qualify: https://redcap.urmc.rochester.edu/redcap/surveys/?s=XHH9MC8RMK

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Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo

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Decidetexto: Mobile Cessation Support for Latino Smokers

Lead Researcher: Anapaula Cupertino

Latino smokers (N = 618) will be randomized to one of two conditions: 1) Decídetexto or 2) standard of care. Decídetexto is a mobile smoking cessation intervention (available in English and Spanish) that incorporates three integrated components: 1) a tablet-based software that collects smoking-related information to develop an individualized quit plan, 2) a 24-week text messaging counseling program with interactive capabilities, and 3) pharmacotherapy support. Decídetexto follows the Social Cognitive Theory as theoretical framework. Standard of care consists of printed smoking cessation materials along with referral to telephone quitline. Participants in both groups are given access to free pharmacotherapy (nicotine patches or gum) by calling study phone number. All participants will complete follow-up assessments at Week 12 and Month 6.

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Developmental Impact of NICU Exposures (DINE)

Lead Researcher: Gloria Pryhuber

Entry into the DINE study requires prior enrollment in the Prematurity and Respiratory Outcomes Program (PROP) or the Impact of Respiratory Virus Infections and Bacterial Microbiome Shifts/PRISM study. If you have not participated in these studies in the past you will not be eligible for this trial. The DINE study will test the hypothesis that potentially avoidable NICU-based exposures contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates. This hypothesis is drawn from the documented impact of phthalate exposure on early development in term-born children, and the acknowledged presence of these toxic chemicals in the NICU. Third trimester in utero exposure to phthalates have been linked to poorer childhood performance in cognition, motor function, attention, hyperactivity and social behavior. Phthalate exposure is also associated with altered onset of puberty and asthma. The multi-site cohort and approach will clarify the role of NICU-based phthalate exposure on high-prevalence clinical outcomes.

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Diet And Nutrition In Cancer (The DANICA study)

Lead Researcher: Luke Peppone

This study will assess the feasibility of delivering an 8-week Mediterranean Diet intervention as well as the intervention's preliminary efficacy on cancer-related fatigue among patients undergoing chemotherapy, compared to usual care. In the first 4 weeks of the intervention, we will provide the participants with food and educate them on the principles and components of the Mediterranean Diet, while in the second 4 weeks participants will prepare their own food. In addition, we will evaluate changes in metabolism and mitochondrial function during 4 weeks of chemotherapy and determine how adherence to a Mediterranean diet modulates these changes during these 4 weeks. The hypothesis is that the intervention will promote adherence to the Mediterranean Diet. The second hypothesis is that adherence will be associated with alleviation of fatigue and improvements in metabolic and mitochondrial function.

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DRO 70001/ Cognitive changes in patients receiving partial brain radiation/ Michael Milano

Lead Researcher: Sara Hardy

Cranial radiation therapy (RT), commonly used to treat benign and malignant brain tumors, can lead to cognitive impairments in domains not related to neuroanatomic structures directly impacted by the tumor. The study will prospectively enroll 58 patients with benign and low-grade brain tumors who will undergo partial brain RT, with either conventionally fractionated or hypofractionated schedules. Subjects will receive MRI scans at baseline and 6 months. Given the role of the limbic system in key cognitive functions affected by RT, researchers have a particular interest in characterizing MRI changes in the limbic system and thalamus in relation to memory and related processes. Specific Aims: To examine objective neurocognitive changes over time. The investigators hypothesize that they will see RT-induced neurocognitive impairment in up to 50% of patients after cranial RT. To examine changes in brain tissue (via MRI) induced by off-target RT in patients with benign and low-grade brain tumors. The investigators specifically hypothesize that comapping of RT dose and MRI changes in the thalamus and limbic system (i.e., thalamic nuclei, hippocampus, fornix, hypothalamus/mammillary bodies, limbic lobe, cingulum) will be most distorted by off-target RT. To examine the relationship between MRI changes for key neuroanatomic structures identified in Aim 1 with objective neurocognitive testing. The investigators hypothesize that cognitive decline will be correlated with damage revealed by MRI to limbic and thalamic structures. This research will help to define which neuroanatomic structures are most at risk from RT-induced damage and will help ultimately establish new dose constraint guidelines for important structures to improve cognitive outcomes.

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DRO-1801: UGIC18078 Short Course Radiation Therapy: Alan Katz

Lead Researcher: Alan Katz

The purpose of this study is to determine if a short course of radiation therapy is effective to treat rectal cancer in older patients. A shorter course of radiation treatment may be better tolerated than a longer course or surgery for the treatment of rectal cancer in the elderly.

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Duke 100510: Phase II study of Dose-Reduced Consolidation Radiation Therapy in Patients with Diffuse

Lead Researcher: Louis Constine

This phase II study will evaluate whether a reduction in radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity . Hypothesis: The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET-CT scan following rituximab - containing chemotherapy.

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ERG Components in Schizophrenia and Bipolar Disorder Type I

Lead Researcher: Steven Silverstein

This study will further assess electroretinogram (ERG) components obtained with different ERG devices, to be considered in a prediction model for each diagnosis. The prediction models are diaMentis proprietary software used as an ERG-based diagnostic test (classified as a Software as a Medical Device, SaMD) to support the diagnosis of schizophrenia and bipolar disorder type I. They involve the processing and analysis of specific retinal biosignatures (RSPA) with the support of statistical and mathematical modelling processes e.g. machine learning and statistical learning.

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Evaluating Social Networks for Adults with Advanced Cancer: A Pilot Feasibility Study

Lead Researcher: Supriya Mohile

The purpose of this study is to learn how older adults with cancer seek information from their social networks (family, friends, clergy, or other people they are close with) and how they use information they’ve gathered to make decisions about treatment for their cancer.

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Evaluation of multiple biomarkers to estimate risk of cancer in gynecology patients presenting with a pelvic mass

Lead Researcher: Richard Moore

The purpose of this study is to validate and refine a technology that can help physicians determine whether an abnormal pelvic mass in women is benign (non-cancerous) or malignant (cancerous) using a blood test. The specific technology is called ParsortixTM PC1 system, a semi-automated system capable of capturing and harvesting rare cells for subsequent analysis from blood based on the size and deformability of the cells.

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Expanded Access Program of Ponatinib

This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) who have failed all available treatment options.

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GA-CARES/ Jacob Nadler/ SMLT1799

Lead Researcher: Jacob Nadler

This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane, or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.

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Graphic Messages to Prevent E-Cigarette Use Among Black and Latino Adolescents

Lead Researcher: Francisco Cartujano barrera

The aim of this study is to determine if graphic messages prevent future vaping among Black and Latino adolescents. The images have been developed in a user-design model and include four main themes: health reward, financial reward, self-efficacy, and social norms. We will assess pre- and post-exposure reactions on likelihood of future vaping.

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Hearing Study: Sensitivity to Features of Speech Sounds

Lead Researcher: Laurel Carney

The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear. We are recruiting listeners with either normal hearing or hearing loss. All listeners will have their hearing tested at the beginning of the study.

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Hematopoietic Stem Cell Transplantation: Evaluation of Investigational Cryopreserved Cord Blood Units (CBUs)

Lead Researcher: Omar Aljitawi

The purpose of this study is to document and evaluate all problems that may occur with the use of investigational cord blood units. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems. The cord blood units in this study have been collected, processed, tested and stored by the National Cord Blood Program and meet the criteria for transplantation as approved by NetCord-FACT (Foundation for the Accreditation of Cellular Therapy).

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HOPE-Helping Older People Engage

Lead Researcher: Kimberly Van Orden

The purpose of this study is to compare two activities — reflecting on one’s past (called “life review”) and volunteering. We are interested in learning how these activities may improve social connectedness and well-being among adults age 60 and older. Additionally, we may ask questions about social distancing, so to that end this study is relevant to managing the psychosocial implications of COVID-19. Volunteering involves participate weekly in a flexible volunteer program with Lifespan. Volunteer activities can be done from your home, such as friendly calling. Life review involves participating in a one-year reminiscence program that is self-guided and involves completing monthly exercises such as writing about one’s memories.

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Hydrocortisone for premature babies

Lead Researcher: Carl D'angio

The Hydrocortisone and Extubation study will test if giving hydrocortisone for 10 days improves survival for premature infants who have a breathing tube. Infants will either receive hydrocortisone or placebo.

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IBMT19183 / Lipe / JNJ-68284528MMY3002 / MMY / CARTITUDE-4

Lead Researcher: Brea Lipe

The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).

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IBRS19007 / FLEX Registry / Ajay Dhakal

Lead Researcher: Ajay Dhakal

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

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IBRS20001, Falkson, PrE0113, Breast cancer, Pelareorep Avelumab Paclitaxel

Lead Researcher: Carla Falkson

The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy [paclitaxel] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 negative(HER2-) breast cancer, which is either locally advanced or has metastasized (cancer that has spread in your body). The study will investigate if pelareorep in combination with paclitaxel and avelumab is more effective than paclitaxel alone, or pelareorep and paclitaxel. The safety of the combination treatments will also be evaluated.

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IBRS20071 / J2J-MC-JZLA (b) / Ajay Dhakal

Lead Researcher: Ajay Dhakal

The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.

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IBRT17055 / BBI-DSP7888-201G / Nimish Mohile

Lead Researcher: Nimish Mohile

This is an event driven, adaptive design, a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 3 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.

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IGIH19161, Hezel, NuTide:121, Hepatoboliary, NUC-1031

Lead Researcher: Aram Hezel

NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care

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IGUB20054, Fung, SGN22E-002, Urothelial Cancer, enfortumab vedotin (EV), pembrolizumab

Lead Researcher: Chunkit Fung

This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.

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IGUK19181, Sahasrabudhe, MK6482-005, Renal Cell Carcinoma, Everolimus

Lead Researcher: Deepak Sahasrabudhe

The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.

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ILEU17106 / ARO-021 / Jane Liesveld

Lead Researcher: Jane Liesveld

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

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ILEU18074 / GMI-1271-301 / Jane Liesveld

Lead Researcher: Jane Liesveld

This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML

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ILEU18153 / PTC299 in R / R Acute Leukemias / Michael Becker

Lead Researcher: Michael Becker

This is an open-label, non-randomized, Phase 1b study to evaluate the safety, pharmacokinetics (PK) profiles, and preliminary evidence of antitumor activity of PTC299 and the metabolite, O-desmethyl PTC299, in participants with relapsed/refractory acute myeloid leukemia (AML) who have exhausted standard available therapies known to provide clinical benefit. The study is designed as a series of cohort-based dose escalations. For each cohort, a minimum of 3 evaluable participants with PK and safety data will be assessed. Additional participants will be recruited if additional PK data are needed to assess mean exposure based on the observed variability.

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ILEU19039 / PrECOG / Kristen O'Dwyer

Lead Researcher: Kristen O'Dwyer

Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 70 will be randomized to receive gilteritinib or midostaurin during induction and consolidation. Patients will also receive standard chemotherapy of daunorubicin and cytarabine during induction and high-dose cytarabine during consolidation. Gilteritinib, is an oral drug that works by stopping the leukemia cells from making the FLT3 protein. This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective. Gilteritinib has been approved by the Food and Drug Administration (FDA) for patients who have relapsed or refractory AML with a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML, and its use in this setting is considered investigational. Midostaurin is an oral drug that works by blocking several proteins on cancer cells, including FLT3 that can help leukemia cells grow. Blocking this pathway can cause death to the leukemic cells. Midostaurin is approved by the FDA for the treatment of FLT3 AML. The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving combination chemotherapy for FLT3 AML.

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ILEU20028 / Mendler / CMBG453B12301

Lead Researcher: Jason Mendler

This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who have an indication for treatment with azacitidine in first-line setting and are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator. The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with IPSS-R intermediate, high, very high risk MDS and CMML-2.

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ILUN19174, Mulford, QUILT-2.023, NSCLC, N803

Lead Researcher: Deborah Mulford

This is a phase 3, open-label, 3-cohort, randomized study to compare the safety and efficacy of N-803 in combination with the current standard of care (experimental arms) versus standard of care alone (control arms), as first-line treatment for subjects with stage 3 or 4 advanced or metastatic NSCLC. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the investigator feels that it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months after the first dose of study drug.

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ILYM15080 / ZUMA-2 / Patrick Reagan

Lead Researcher: Patrick Reagan

The primary objective of the study is to evaluate the efficacy of brexucabtagene autoleucel (KTE-X19) in participants with relapsed/refractory mantle cell lymphoma (MCL)

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ILYM17064 / RSRB70432 / Paul Barr

Lead Researcher: Paul Barr

Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL

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ILYM18152 / VLS-101-0001 / Paul Barr

Lead Researcher: Paul Barr

The purpose of this study is to evaluate the safety, pharmacokinetics, immunogenicity, and efficacy of zilovertamab vedotin given intravenously (IV) across a range of dose levels in participants with previously treated hematological cancers including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), Burkitt lymphoma (BL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), Richter transformation lymphoma (RTL), and T-cell non-Hodgkin lymphoma (NHL).

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ILYM19167, Reagan, mRNA-2752-P101, Lymphoma, mRNA-2752

Lead Researcher: Patrick Reagan

The clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.

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IMEL20059 / UV1-202 / Adrienne Victor

Lead Researcher: Adrienne Victor

UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma. This study will explore the Efficacy and Safety of UV1 administered with GM-CSF in combination with nivolumab and ipilimumab.

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IMMY18128 / Seattle / Brea Lipe

Lead Researcher: Brea Lipe

This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur. The study will have three parts. In the first part, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works. In the second part of the study, participants will get SEA-BCMA and dexamethasone. In the third part, participants will get SEA-BCMA, dexamethasone, and either pomalidomide or nirogacestat. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. Nirogacestat is an experimental drug that can be used with SEA-BCMA to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.

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IMMY19114 /CC-220-MM-001/ Brea Lipe

Lead Researcher: Brea Lipe

This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.

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IMMY20022/CAEL101-301/Frank Passero

Lead Researcher: Frank Passero

AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine if CAEL-101 improves the overall survival in Patients with cardiac AL Amyloidosis.

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IMMY20043/ HPN217 /Brea Lipe

Lead Researcher: Brea Lipe

An open-label, Phase 1/2 study of HPN217 as monotherapy to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma

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IMMY20058 /CAEL101-302/ Frank Passero

Lead Researcher: Frank Passero

AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine if CAEL-101 improves the overall survival in Patients with cardiac AL Amyloidosis.

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IMMY20144/ 64407564MMY1001/ Brea Lipe

Lead Researcher: Brea Lipe

The purpose of this study is to evaluate the efficacy of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

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Improving Well-Being for Older Adult Family Dementia Caregivers

Lead Researcher: Kathi Heffner

The purpose of the study is to examine the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well (LW) for Dementia Caregivers program, compared to any usual care, to see if the programs might be associated with better immune function, physical and emotional health, and well-being. This study is looking for individuals age 55 and up who are caring for someone (such as a spouse, parent, close friend) who has dementia. Participation includes attending a weekly small group meeting at Lifespan over eight weeks for one of two study programs (determined randomly). Both programs address ways of improving physical and emotional well-being in the context of dementia caregiving.

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Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)

This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.

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Lorcaserin for Treating Patients with Dravet Syndrome (Epilepsy)

Lead Researcher: Inna Hughes

There is a Core Study and an Extension Phase. The Core Study will include a Pre-randomization (Baseline) and a Randomization (Treatment) Phase. The Pre-randomization Phase will include a Screening/Baseline Period (4 weeks), during which the subjects will be assessed for eligibility. Once the Screening and Baseline procedures have been completed and eligibility has been established, the subjects will be randomized to 1 of 2 treatment groups in a ratio of 1:1 and will receive lorcaserin or placebo for 14 weeks. All subjects who complete the Core Study will be eligible to enter the 16-week Open-label Extension Phase. Eligibility: Aged 2 or older with a diagnosis of Dravet syndrome.

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Lymphoma & Leukemia: Collection of specimens and epidemiological and clinical outcomes data in patients with hematological malignancies

Lead Researcher: Walter Burack

This research is being done because we hope that a better understanding of hematologic malignancies will allow us to develop new and better treatments.

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Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma

Lead Researcher: Angela Girvin

This partially randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

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Management of the PDA Trial

Lead Researcher: Carl D'angio

Patent ductus arteriosus (PDA) is an extra blood vessel found in babies before birth and just after birth. In most babies who have an otherwise normal heart, the PDA will shrink and close on its own in the first few days of life. If it stays open longer, it may cause extra blood to flow to the lungs. This study estimates the risks and benefits of active treatment versus expectant management of premature babies with patent ductus arteriosus.

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Measuring Surgical Recovery After Radical Cystectomy

The intent of this study is to establish a registry of post‐surgical outcomes in patients undergoing radical cystectomy. The goals of this initiative are to obtain a detailed baseline of multiple patient‐reported outcomes (PRO) and clinician‐reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.

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Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial

Apnea of prematurity (AOP) is a condition in which premature infants stop breathing for 15 to 20 seconds during sleep. The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.

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Multiple Myeloma

Lead Researcher: Brea Lipe

The purpose of this study is to collect clinical data along with bone marrow aspirate samples to see if there is a way to determine which patients are more or less likely to experience disease progression. This study will involve identifying different markers on the surfaces of the plasma cells and will look at protein expression. We will then correlate those findings with data from your medical records over time. If you decide to take part in this study, you will be asked to allow additional bone marrow aspirate and blood samples to be collected for research at several time points. These additional samples will be collected during routine testing time points as required for your routine care. We will also collect information about your disease and treatment from your medical record.

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Multiple Myeloma: Integrating Touchscreen-based Geriatric Assessment and Frailty Screening for Adults with Multiple Myeloma to Drive Personalized Treatment Decisions

Lead Researcher: Supriya Mohile

If you enter the study, you will be asked to complete an electronic questionnaire on a sponsor- provided electronic tablet during an already scheduled clinical visit to your medical oncology doctor’s office. The questionnaire will take about 10 minutes to complete; study staff will remain available to assist you.

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Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophy Registry

Lead Researcher: Al-rabi Tawil

Myotonic dystrophy (DM) and facioscapulohumeral muscular dystrophy (FSHD) are inherited disorders characterized by progressive muscle weakness and loss of muscle tissue. The purpose of this registry is to connect people with DM or FSHD with researchers studying these diseases. The registry will offer individuals with DM and FSHD an opportunity to participate in research that focuses of their diseases. The registry will also help scientists to accomplish research on DM and FSHD and to distribute their findings to patients and care providers.

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NRG GU005 SBRT vs IGRT and Hypo-fractionated IRT Intermediate Risk Prostate

Lead Researcher: Yuhchyau Chen

This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.

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NRG GU007 / CGUP19100 Androgen Deprivation Therapy in high risk Prostate cancer

Lead Researcher: Hong Zhang

This phase II trial studies the side effects and best dose of niraparib, and to see how well it works in combination with standard of care radiation therapy and hormonal therapy (androgen deprivation therapy) in treating patients with prostate cancer that has a high chance of coming back (high risk). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding niraparib to the usual treatments of radiation therapy and hormonal therapy may lower the chance of prostate cancer growing or returning.

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NRG HN001/ Individualized Treatment for Naso-pharyngeal Carcinoma EBV positive/ Yuhchyau Chen

Lead Researcher: Yuhchyau Chen

There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

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NRG LU005/ Chemo-radiation versus Chemo-radiation plus Atezolizumab/ Yuhchyau Chen

Lead Researcher: Yuhchyau Chen

This phase III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.

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NRG-LU002/ Maintenance Systemic Therapy/ Yuhchyau Chen

Lead Researcher: Michael Milano

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without local consolidation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, erlotinib hydrochloride, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Local consolidation therapy such as radiation/stereotactic body radiation or surgery may kill cancer cells left after initial treatment. Giving maintenance chemotherapy and local consolidation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

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Outcome Disparities in Adolescents with Acute Lymphoclastic Leukemia (ALL)

Lead Researcher: Kristen O'Dwyer

We will establish two prospective groups of patients with Acute Lymphoclastic Leukemia (ALL): "Cohort A" will be enrolled on the study at the time of diagnosis while "Cohort B" will be enrolled during maintenance chemotherapy.

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PBRN00002 / ANBL00B1 / Angela Girvin

Lead Researcher: Angela Girvin

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

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PBRN18054 / ANBL1531 / Angela Girvin

Lead Researcher: Angela Girvin

This phase III trial studies iobenguane I-131 or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or crizotinib and standard therapy may work better compared to crizotinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

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PBRT14096 / ANBL1232 / Angela Girvin

Lead Researcher: Angela Girvin

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

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PBRT17119 / ACNS1422 / Angela Girvin

Lead Researcher: Angela Girvin

This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

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PCCB17098 / APEC1621SC / Angela Girvin

Lead Researcher: Angela Girvin

This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

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PCCO15102 / APEC14B1 / EveryChild Protocol / Angela Girvin

Lead Researcher: Angela Girvin

This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

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PGUK06001 / AREN03B2 / Angela Girvin

Lead Researcher: Angela Girvin

This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

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Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

Primary Biliary Cholangitis (PBC) formerly known as primary biliary cirrhosis is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) helps prevent liver damage and improves liver function. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.

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PHEM15022 / PIDTC-6901 / Jeffrey Andolina

Lead Researcher: Jeffrey Andolina

This study is a prospective evaluation of children with Severe Combined Immune Deficiency (SCID) who are treated under a variety of protocols used by participating institutions. In order to determine the patient, recipient and transplant-related variables that are most important in determining outcome, study investigators will uniformly collect pre-, post- and peri-transplant (or other treatment) information on all children enrolled into this study. Children will be divided into three strata: Stratum A: Typical SCID with virtual absence of autologous T cells and poor T cell function Stratum B: Atypical SCID (leaky SCID, Omenn syndrome and reticular dysgenesis with limited T cell diversity or number and reduced function), and Stratum C: ADA deficient SCID and XSCID patients receiving alternative therapy including PEG-ADA ERT or gene therapy. Each Group/Cohort Stratum will be analyzed separately.

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PHEM15023 / PIDTC-6903 / Jeffrey Andolina

Lead Researcher: Jeffrey Andolina

Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which bone marrow transplantation (BMT) has been shown to be curative. However the risks of transplantation are high and not all patients with CGD may need to undergo this high risk procedure. This study will determine the long term medical condition and daily functioning of participants with CGD after a transplant and if possible, compare these results to participants who do not undergo a transplant.

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PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry

The objective of this study is to evaluate the safety of long-term treatment with Kuvan.

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Plant-Based Nutrition in Metastatic Breast Cancer

Lead Researcher: Thomas Campbell

This research will examine the feasibility of conducting a strict whole-food, plant-based dietary intervention in women with stable metastatic breast cancer currently undergoing conventional treatments. In addition, this research will provide preliminary data on dietary intakes and the effect of plant-based nutrition on numerous outcomes reflecting cancer prognosis and overall health using advanced imaging, various blood biomarkers linked to cancer progression, and numerous symptom questionnaires.

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PLEU16099 / AAML1531 / Angela Girvin

Lead Researcher: Angela Girvin

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

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PLEU17115 / AALL1621 / Angela Girvin

Lead Researcher: Angela Girvin

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

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PLEU18029 / AALL1631 / Angela Girvin

Lead Researcher: Angela Girvin

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

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PLEU19145 / AAML18P1 / Angela Girvin

Lead Researcher: Angela Girvin

This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.

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PLEU19175 / AALL1732 / Angela Grivin

Lead Researcher: Angela Girvin

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

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PLEU20095 / AAML1831 / Angela Girvin

Lead Researcher: Angela Girvin

This phase III trial compares standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

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PMLT12010 / ALTE05N1 / Angela Girvin

Lead Researcher: Angela Girvin

This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

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PMLT18041 / AGCT1531 / Angela Girvin

Lead Researcher: Angela Girvin

This phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

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PMLT21052 / APEC1621A / Girvin

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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PMLT21055 / APEC1621D / Angela Girvin

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well samotolisib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR mutations that have spread to other places in the body (metastatic) and have come back (recurrent) or do not respond to treatment (refractory). Samotolisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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PMLT21057 / APEC1621F / Angela Girvin

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or do not respond to treatment (refractory) and have spread to other places in the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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PMLT21059 / APEC1621H / Angela Girvin

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well olaparib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic acid (DNA) damage repair genes that have spread to other places in the body (advanced) and have come back (relapsed) or do not respond to treatment (refractory). Olaparib is an inhibitor of PARP, an enzyme that helps repair DNA when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.

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PMLT21060 / APEC1621I / Angela Girvin

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations (mutations) in cell cycle genes that have spread to other places in the body and have come back or do not respond to treatment. Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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PMLT21061 / APEC1621K / Girvin

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well ivosidenib works in treating patients with solid tumors that have spread to other places in the body (advanced), lymphoma, or histiocytic disorders that have IDH1 genetic alterations (mutations). Ivosidenib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway called the IDH pathway.

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PMLT21062 / APEC1621M / Angela Girvin

Lead Researcher: Angela Girvin

This phase II pediatric MATCH trial studies how well tipifarnib works in treating patients with solid tumors that have recurred or spread to other places in the body (advanced), lymphoma, or histiocytic disorders, that have a genetic alteration in the gene HRAS. Tipifarnib may block the growth of cancer cells that have specific genetic changes in a gene called HRAS and may reduce tumor size.

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Preemie Hypothermia for Neonatal Encephalopathy

Lead Researcher: Carl D'angio

Encephalopathy is a general term that means brain disease, damage, or malfunction. This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.

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PROMISE - For Pregnant Women

Lead Researcher: Sheree Toth

The PROMISE Program is for low income adult pregnant women and their babies once they are born. If you participate, you would have a 75% chance of receiving free counseling through the Child Parent Program for 6-12 months, which can strengthen your relationship with your baby and promote positive parenting. You would also receive a referral to a local community agency that can help with your pregnancy, and securing needs. Counseling and study visits can be completed online or in person. You would be asked to complete 4-7 study visits, starting during pregnancy and ending when your baby turns 15 months old. You can receive up to $335 by completing study visits.

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PSAR16117 / ARST1431 / Angela Girvin

Lead Researcher: Angela Girvin

This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether chemotherapy plus temsirolimus is more effective than chemotherapy alone in treating patients with intermediate-risk rhabdomyosarcoma.

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RAISE: A Study of Ganaxolone for Treatment of Status Epilepticus

Lead Researcher: Trenton Tollefson

Potential participants may be identified in the emergency department, ICU or other units in the hospital, and will be consented/assented and then screened for inclusion/exclusion criteria prior to being randomized to start IP treatment. Investigational product (ganaxalone) will be administered as a 3-minute bolus that will be started with a continuous IV infusion lasting for 36 hours and followed by a 12- hour taper. After the Investigational Product has been discontinued, the follow-up period assessments/procedures will be collected every 24 hours through 120 hours and at the time of hospital discharge followed by weekly visits/contacts at Week 1, 2, 3 and 4. Males or females aged 18 or older and admitted to the hospital in a state of status epilepticus are eligible. Patients with a history of status epilepticus may pre-consent to participate in the study.

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RBRT19176, Milano, A071801, Metastatic Brain Disease, Radiation

Lead Researcher: Michael Milano

This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.

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REALIZE: CVL-865 to Treat Epilepsy

Lead Researcher: Trenton Tollefson

This placebo-controlled, double-blind trial is designed to assess the efficacy, safety and tolerability profile of CVL-865 as adjunctive treatment in subjects with drug-resistant focal onset seizures. Subjects will be randomized into one of three arms in a 1:1:1 ratio: one of two formulations of the study drug and placebo. For more information, go to Realizestudy.com

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Registry of Full-genome Data Linked with Clinical Data to Evaluate New Gene Associations in Breast Cancer

Lead Researcher: Ajay Dhakal

The purpose of this registry is to create a large-scale, population-based database. This database will match health information to genome data to identify new gene associations in breast cancer. The study will look at Agendia Breast Cancer tests, including MammaPrint® and BluePrint™, which are tests that help doctors analyze and profile breast cancer tumors.

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RGIC19164, Qiu, EA2182, Colon/Rectal, Capecitabine, Fluorouracil, Mitomycin,

Lead Researcher: Haoming Qiu

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

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RLUN20118 / NRG-LU007 / Qiu

Lead Researcher: Haoming Qiu

This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.

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RMLT20073 / AVATAR / Constine

Lead Researcher: Louis Constine

To determine the success rate of the AVATAR audio-visual system. All patients enrolled in the study will be counted, and each patient who is able to undergo at least one fraction without anesthesia will count as a success while each patient who does not have at least one fraction without anesthesia will count as a failure. The success rate will be the proportion of patients who are successes.

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RTOG 1216/ RHAN13055/ Surgery and Postoperative Radiation/ Yuhchyau Chen

Lead Researcher: Yuhchyau Chen

This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

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Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 104. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

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Selumetinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well selumetinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations that have spread to other places in the body and have come back or do not respond to treatment. Selumetinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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Silverlon to reduce radiation dermatitis/ Julie Wolf

Lead Researcher: Julie Wolf

The purpose of this study is to see if a silver-nylon dressing (Silverlon®, Argentum Medical) is useful for the prevention or treatment of radiation dermatitis in patients receiving radiation therapy to the breast.

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Study of Arimoclomol in Inclusion Body Myositis (IBM)

Lead Researcher: Elizabeth Luebbe

Funding Source - FDA OOPD. The purpose of this study is to evaluate the safety and efficacy of the study drug, Arimoclomol in IBM patients.

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Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.

The purpose of the study is to determine whether T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.

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STUDY00005613: RLUN20119 / A081801 / Chen

Lead Researcher: Yuhchyau Chen

This phase III ALCHEMIST trial compares the addition of pembrolizumab to usual chemotherapy versus usual chemotherapy for the treatment of stage IIA, IIB IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The purpose of this trial is to find out if the addition of pembrolizumab to usual chemotherapy is better or worse than usual chemotherapy alone for non-small cell lung cancer.

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Studying Infant Nutrition and Blood Sugar in Breastfed Infants

Lead Researcher: Bridget Young

This study is for pregnant women who plan on breastfeeding their baby for at least 5 months. You and your baby will have two study visits over the first 6 months of your baby's life at the University of Rochester Medical Center. We will ask for some blood and some breast milk from you. We will ask for some urine and stool, and a heel prick from your baby.

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SWOG 1806 Chemo-Radiotherapy with / without Atezolizumab in localized muscle Invasive Bladder cancer

Lead Researcher: Michael Cummings

This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

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Talk Therapy by Phone to Promote Treatment for Alcohol Problems

Lead Researcher: Kenneth Conner

A small percentage of individuals with alcohol use disorder (AUD) obtain alcohol-related care despite research showing that treatment is effective. This randomized controlled trial tests the efficacy of a brief, phone based cognitive behavioral intervention to increase treatment engagement, improve alcohol related outcomes, and show that treatment engagement is a mechanism for the improved outcomes in individuals with AUD. This study will also asses the impact of COVID-19 on alcohol use and other quality of life measures.

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The Early Treatment for Retinopathy of Prematurity Study (ETROP)

The goal of the Early Treatment for Retinopathy of Prematurity Study (ETROP) is to test the hypothesis that earlier treatment in carefully selected cases will result in an overall better visual outcome than treatment at the conventional CRYO-ROP threshold point in the disease.

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The REPLACE Registry-for people who take Cholbam/Kolbam (Cholic Acid)

Lead Researcher: Nanda Kerkar

This is a study for people who take Cholbam/Kolbam also known as Cholic acid. You will be in this study for 10 years and we will collect information about your health.

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To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter

The purpose of this study is to determine the optimum effective dose of recombinant plasmid DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct injection catheter (Stiletto™) system needed to benefit patients with severe Angina Pectoris.

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Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.

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UBMT15029 / Liesveld Cord Blood IIT / Omar Aljitawi

Lead Researcher: Omar Aljitawi

This study is a single-center, treatment protocol with 4 possible preparative regimens, designed to validate the process of umbilical cord blood stem cell transplantation at our institution.

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UBMT16009 / MSKCC15 / Michael Becker

Lead Researcher: Michael Becker

The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.

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UBMT17044 / HBO-UBC / Omar Aljitawi

Lead Researcher: Omar Aljitawi

The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs).

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UBMT17083 / STUDY00001522 / Omar Aljitawi

Lead Researcher: Omar Aljitawi

Patients with Multiple Myeloma who are considered for high-dose therapy and autologous transplantation at the bone marrow transplant clinic at the Wilmot Cancer Institute (WCI) will be be approached to participate in this trial. Eligible patients who choose to participate will be randomized so that half receive one hyperbaric oxygen therapy session prior to hematopoetic stem cell infusion and half will not. All subjects will have their blood counts monitored closely and time to count recovery will be compared between the two groups.

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UCCS19151, Janelsins, Cancer, Cognitive Assessment via Electronic Platform

Lead Researcher: Michelle Janelsins-Benton

The purpose of this study is to test the feasibility (acceptability and usability) and usefulness of the CAMPFIRE (Cognitive Assessment and Monitoring Platform for Integrative Research) system, a patient-facing portal able to collect and produce reports for clinicians on Patient Reported Outcome Measurement Information System (PROMIS-Cognitive Function/Anxiety/Depression) outcomes via MyChart and NIH Toolbox, an inperson brief objective cognitive function battery. This study will aim to determine the value of the CAMPFIRE system for patients and providers as a tool for monitoring cognitive symptoms throughout the course of chemotherapy

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UCCS19158, Karen Mustian, YOCAS

Lead Researcher: Karen Mustian

This phase II randomized controlled trial examines the preliminary efficacy of our standardized four-week YOCAS©® program (Yoga for Cancer Survivors) on insomnia and sleep quality in cancer survivors and their caregivers. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. The majority of patients with cancer experience some form of sleep disturbance. Caregivers who provide significant physical, emotional, and psychosocial care for patients with cancer also experience sleep disturbance. Yoga is safe, feasible, and effective for improving insomnia and sleep quality in cancer survivors. However, whether both cancer survivors and their caregivers can both improve their insomnia and sleep quality by participating in partnered yoga intervention is not known.

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UCCS20127 / Magnuson / MAAT-G Phase II

Lead Researcher: Allison Shifflet

Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising treatment for CRCD that improves perceived cognition in younger cancer survivors, but needs to be adapted for older adults to address their unique needs. The proposed study will adapt MAAT for older adults using feedback from key stakeholders (older adults with cancer and their caregivers), and subsequently test the ability of MAAT to improve or maintain cognition for older adults with breast cancer receiving adjuvant chemotherapy.

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UGIC18095 / 00003244 / Richard Dunne

Lead Researcher: Richard Dunne

The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery.

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UGIE17037 / Dunne mFOLFOX + Chemo IIT / Richard Dunne

Lead Researcher: Richard Dunne

Evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant recurrence among patients with locally advanced esophageal cancer.

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UGIP20027, Dunne, CA209-7WU, Pancreatic Ductal Adenocarcinoma, SX-682, Nivolumab

Lead Researcher: Richard Dunne

The main purpose of this research study is to determine the maximum tolerable dose (MTD) of SX-682 in combination with nivolumab in patients with metastatic pancreatic ductal adenocarcinoma who have completed at least 16 weeks of first line chemotherapy treatment without evidence of disease progression.

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UGUB20041, Fung, HCRN GU18-343, Urinary Bladder Neoplasms, Cabozantinib, Atezolizumab

Lead Researcher: Chunkit Fung

This is an open-label phase II study assessing the activity of cabozantinib combined with atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals 21 days. The dose of atezolizumab is 1200 mg IV flat dose every 3 weeks (Day 1) plus cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients will receive three cycles of treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw consent.

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UGUK17036 / Fung RCC Carevive Pilot IIT / Chunkit Fung

Lead Researcher: Chunkit Fung

To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.

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UGUP17050 / Deepak Cisplatin Pilot IIT / Deepak Sahasrabudhe

Lead Researcher: Deepak Sahasrabudhe

It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to enzalutimide in patients with CRPC by affecting AR function.

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UGUP18071 / DORA / Chunkit Fung

Lead Researcher: Chunkit Fung

The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself.

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UGYO17017 / MD Anderson / Richard Moore

Lead Researcher: Richard Moore

The goal of this clinical research study is to evaluate a method involving a blood test, called CA-125, that may be helpful in the early detection of ovarian cancer in women who are at low risk.

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ULAB03012 / LEO / Richard Burack

Lead Researcher: Walter Burack

The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors, as well as the interaction among these factors, on short and long-term outcomes. These efforts will identify new approaches to improve the survival and well-being of NHL patients.

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ULEU07047 / RSRB20123 / Michael Becker

Lead Researcher: Michael Becker

This study is being performed to develop assays to determine the impact of the therapy patients receive for treatment of AML or MDS and to determine if these tests can identify those patients who are at a greater risk for having their disease relapse.

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ULEU18122 / Huselton WashU AML IST / Eric Huselton

Lead Researcher: Eric Huselton

The investigators will prospectively determine whether the relapse-free and overall survival in patients who have cleared their leukemia-associated mutations treated with standard consolidation chemotherapy is superior to what is expected based on historical controls. The investigators will also prospectively determine the relapse-free and overall survival of patients who have not cleared their mutations. Because the relapse rate of patients with persistent mutations is expected to be high, treatment with either standard of care consolidation therapy alone or alloSCT will be permitted, at the discretion of the treating physician.

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ULUN18075/ RSRB72835 / Deepinder Singh/ Lung 3 vs 5 Fx SBRT

Lead Researcher: Deepinder Singh

This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment. Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation. After patients complete radiation treatment, they will follow up with their radiation oncologist.

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ULUN19148 / Pembrolizumab NSCLC / Megan Baumgart

Lead Researcher: Megan Baumgart

The purpose of this study is to understand if treatment with one chemotherapy medication combined with immune therapy (pembrolizumab) is tolerable and effective for patients with lung cancer and performance status of 2 (PS2), which means you have limitations in carrying out certain activities or spend up to half of your day resting.

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ULYM17025 / ILyAD / Jonathan Friedberg

Lead Researcher: Jonathan Friedberg

Despite strong evidence suggesting that vitamin D deficiency is associated with undesirable outcomes in patients with numerous cancers, there has never been a thorough study of vitamin D treatment in subjects undergoing treatment for cancer. The purpose of this study is to evaluate whether modification of vitamin D levels in the blood, through supplementation, can improve outcomes.

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ULYM18040 / DLBCL / Carla Casulo

Lead Researcher: Carla Casulo

The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.

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ULYM20030 / ML41690 Polatuzumab / Patrick Reagan

Lead Researcher: Patrick Reagan

The purpose of this study is to test the effectiveness and safety of polatuzumab vedotin in combination with R-miniCHP in patients 75 years and older with DLBCL.

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UMDS18092 / Mendler MDS Pilot IIT / Jason Mendler

Lead Researcher: Jason Mendler

The primary objective of this study is to determine the safety and tolerability of combined abaloparatide and bevacizumab in patients with Myelodysplastic Syndromes (MDS). A secondary objective is to determine the response to treatment (based on bone marrow and peripheral blood findings). A tertiary objective is to determine the impact of therapy on health-related quality of life (HRQOL) and patient-reported outcomes (PRO). A quaternary (scientific) objective is to determine the impact of treatment on both hematopoietic and stromal cell populations within the bone marrow of MDS patients.

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UMLT18037 / Mayo MC17C1 / Richard Dunne

Lead Researcher: Richard Dunne

This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.

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UMLT19130 / Weight Loss / Richard Dunne

Lead Researcher: Richard Dunne

The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia.

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UMLT19186 / K08 JIT / Ramsdale

Lead Researcher: Erika Ramsdale

This is a single-site cluster-randomized trial to assess efficacy and implementation outcomes of deprescribing interventions in 72 older adults with polypharmacy (PP) and curable cancers initiating chemotherapy. Oncologists (as the cluster) will enroll 6 patients each and will be randomized to either a pharmacist-led deprescribing intervention or patient education intervention. Initial focus groups with oncologists, nurses, pharmacists, primary care physicians, and patients will provide data for initial adaptations to the pharmacist-led intervention arm, and 8 patients will be enrolled as a pre-trial cohort to further refine and adapt the pharmacist-led intervention.

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UMLT21037 / COVID-19 Vaccine / Sahasrabudhe

Lead Researcher: Deepak Sahasrabudhe

To explore the immune response to the COVID-19 vaccine in cancer patients and compare to the general population.

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UMMY20033 /Steroid Sparing Treatment/ Frank Passero

Lead Researcher: Frank Passero

The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.

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Upper GI Tract Cancer: 12 week home-based exercise study

Lead Researcher: Richard Dunne

We would also like to find out if this exercise intervention improves physical performance, day-to-day function, quality of life, and how the exercise may affect markers of inflammation in the blood over time. Cancer cachexia is a complex condition that can result in weight loss, muscle weakness, and/or tiredness, and may affect your normal daily activities and quality of life. Cachexia is common in patients with upper gastrointestinal tract cancers (esophageal, stomach, bile duct or liver cancer, and pancreatic cancer). There is little information on how these symptoms may develop or change as cachexia progresses, or how exercise may help improve these symptoms. Currently more information is needed on how physical performance and quality of life is affected by cachexia. There are no drugs approved for cachexia so understanding cachexia and its effect on the body may guide the development of interventions to help other patients with cancer cachexia.

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URCC 3705/ Genotoxicty Assessment / Yuhchyau Chen

Lead Researcher: Yuhchyau Chen

The purpose of the research study is to evaluate an automated, laser-based technique for measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.

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Vaping/ Peter A. Wyman

Lead Researcher: Peter Wyman

Rates of adolescent vaping are increasing rapidly. Current high school student use of electronic vaping products (EVPs) rose from 1.5% in 2011 to 20.8% in 2018 - an increase from 220,000 to 3.05 million adolescent users. Effective, school-based interventions are urgently needed to protect adolescents from initiating or continuing use of electronic vaping products (EVPs). This study leverages a state-supported prevention initiative to test the effectiveness of a promising intervention that trains 8th-9th grade student peer leaders to deliver school-wide vaping prevention campaigns with ongoing adult mentoring. If study hypotheses are supported, the study will provide the first evidence of a school-based preventive intervention that reduces adolescent vaping behaviors, as well as insight into how peer communications can be harnessed to prevent vaping.

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