A clinical trial is a research study involving human volunteers, and is designed to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find effective treatments, and new ways to improve health.
You can search for all studies that are currently enrolling participants at the University of Rochester by typing in keywords in the search box below. If you don’t find a study that interests you right now, consider signing up for our Volunteer Registry, which will notify you of future studies.
4AP/ UGUP18139/ Ahmed Ghazi
Lead Researcher: Thomas Osinski
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.
View Study Details
A behavioral intervention for post-partum depression
Lead Researcher: Ellen Poleshuck
The purpose of this study is to compare two approaches to delivering an intervention
known to reduce postpartum depression (PPD) – in person groups and a mobile app. You
must be 20-35 weeks pregnant, be a patient at one of five preidentified doctor's offices
and speak English.
View Study Details
A Study of JZP385 in Adults with Moderate to Severe Essential Tremor
Lead Researcher: Irene Richard
This study aims to find out whether an investigational (or experimental) drug called
JZP385 is safe and works in treating moderate to severe essential tremor. Treatment
with JZP385 will be compared to treatment with placebo in this study. A placebo looks
like the investigational drug but does not contain any active medicine. A placebo
is used in studies to see if an investigational drug works better or is safer than
not taking anything at all. Inclusion criteria: Ages 18 to 80, diagnosed with essential
tremor (including ET plus)
View Study Details
A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment
of Focal Onset Seizures
Lead Researcher: Trenton Tollefson
The purpose of this study is to assess the efficacy, safety, and tolerability profile
of
CVL-865 as adjunctive treatment in participants with drug-resistant focal onset seizures.
View Study Details
A081801 / RLUN20119 / ALCHEMIST-IO (ACCIO) / Yuhchyau Chen
Lead Researcher: Yuhchyau Chen
This phase III ALCHEMIST trial tests the addition of pembrolizumab to 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. Giving pembrolizumab with usual chemotherapy
may help increase survival times in patients with stage IIA, IIB IIIA or IIIB non-small
cell lung cancer.
View Study Details
A151216 ALCHEMIST 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.
View Study Details
ADORED-Allergic Disease Onset Prevention Study
Lead Researcher: Kirsi Jarvinen-seppo
Early administration of beneficial bacteria that promote immune tolerance represents
a novel approach for the prevention and treatment of allergic diseases, such as atopic
dermatitis and asthma. STMC-103H is a live biotherapeutic product (LBP) containing
a consortium of
intestinal bacteria that may impact the incidence of allergic sensitization and disease
in
neonates and infants at risk for developing allergy and asthma. STMC-103H is an oral
capsule containing powder which will be mixed with a small amount of breastmilk, the
participant’s formula, or a milk product. Siolta Therapeutics is testing this investigational
drug for the prevention of allergic diseases, including atopic dermatitis (eczema),
food allergy, asthma, and allergic rhinitis (hay fever).
View Study Details
ADVANCED-1/ IGUB21083 / Messing
Lead Researcher: Edward Messing
This study is an open-label dose escalation study (Phase 1a) to investigate the safety
and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including
CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or
biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin
(BCG), adults who have received at least one dose of intravesical BCG or adults who
have received at least one dose of intravesical chemotherapy. Dosing will start in
subjects with HGTa or CIS (including CIS with concomitant Ta), and all subjects will
receive 6 weeks of treatment at a fixed volume with varying dose levels.
View Study Details
Aging and Information Processing
Lead Researcher: Robert Chapman
The purpose of our study is to better understand functional differences in brain activity
between healthy aging and neurodegenerative conditions, such as Alzheimer's Disease.
To do this, our lab uses a noninvasive and inexpensive technique to collect brain
measurements called electroencephalogram (EEG). By recording EEG while participants
do certain memory and other cognitive tests, we can link specific brain signals by
brain location and time to cognitive activities (such as trying to memorize a stimulus).
We collect the EEG, as well as traditional pen-and-paper cognitive test results, from
participants every year. Using these brain measurements, we aim to discover differences
between the healthy aging brain and brains struck by age-related cognitive disorders.
Combining different brain measures together may help us develop better tests for these
disorders.
View Study Details
Algo TX
Lead Researcher: Jennifer Gewandter
The purpose of this clinical trial is to compare the efficacy of twice daily applications
of ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating
chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients.
View Study Details
An EEG Study of Auditory Perception in People with and without Schizophrenia
Lead Researcher: Judy Thompson
The purpose of our study is to better understand how the brain processes sounds, including
speech. We are investigating this in people with and without psychiatric conditions.
One of our primary aims is to determine how these processes may relate to specific
experiences and symptoms in conditions such as schizophrenia, schizoaffective disorder,
and schizophreniform disorder, with the goal of using this knowledge to develop more
effective treatments. In order to study how the brain processes sounds, we use a technique
called electroencephalography, or EEG. For EEG, a person wears a comfortable elastic
cap with sensors attached to it that are able to record brain activity. In these sessions,
subjects listen to short audio clips while EEG is recording; this allows us to measure
brain responses to sounds. This study also includes interviews about current and past
psychiatric symptoms and treatment, as well as a few short tasks, questionnaires,
and a hearing test. The study typically involves 4-5 visits, with each about 2-3 hours
long. Subjects are paid $30 an hour, as well as a $30 bonus if they complete all study
activities. Transportation costs are also covered, and free snacks are provided.
View Study Details
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
View Study Details
BEGIN - A Breastfeeding Study
Lead Researcher: Bridget Young
This study will enroll 120 breastfeeding mothers into a study that lasts between 1-4
months postpartum. Mothers will collect a small breast milk sample very single day
and store it in their freezer for researchers. They will also collect samples from
their infant including urine and stool from the diaper. All sample collections are
done in the home.
View Study Details
Cancer (Geriatric): Cognitive Rehabilitation For At-Risk Older Cancer Patients Receiving
Chemotherapy: A Pilot Study Evaluating Feasibility And Impact
Lead Researcher: Allison Magnuson
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.
View Study Details
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.
View Study Details
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.
View Study Details
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.
View Study Details
CBRT20074 / A071701 / NImish Mohile
Lead Researcher: Nimish Mohile
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, PI3K,
or KRAS G12C. Medications that target these genes such as abemaciclib, paxalisib,
entrectinib and adagrasib 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.
View Study Details
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.
View Study Details
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.
View Study Details
CGIP20087 / A021806 / Richard Dunne
Lead Researcher: Daniel Mulkerin
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).
View Study Details
CGUB19067 / S1600 / William Tabayoyong
Lead Researcher: William Tabayoyong
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.
View Study Details
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.
View Study Details
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.
View Study Details
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.
View Study Details
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.
View Study Details
CGYO20085 / NRG-CC008 / Richard Moore
Lead Researcher: Richard Moore
This clinical trial studies how well two surgical procedures (bilateral salpingectomy
and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for
individuals 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.
View Study Details
CHAN21104 / NRG-HN009 / Patel
Lead Researcher: Arpan Patel
This phase II/III trial compares the effect of the combination of high-dose cisplatin
every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation
therapy for the treatment of patients with locoregionally advanced head and neck cancer.
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. Radiation therapy uses high energy x-rays to kill tumor cells
and shrink tumors. This study is being done to find out if low-dose cisplatin given
weekly together with radiation therapy is the same or better than high-dose cisplatin
given every 3 weeks together with radiation therapy in treating patients with head
and neck cancer.
View Study Details
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.
View Study Details
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.
View Study Details
CLUN19153, Mulford, EA5163/S1709, NSCLC, Carboplatin, Pemetrexed
Lead Researcher: Deborah Mulford
This phase III trial studies whether pembrolizumab alone as a first-line treatment,
followed by pemetrexed and carboplatin with or without pembrolizumab after disease
progression is superior to induction with pembrolizumab, pemetrexed and carboplatin
followed by pembrolizumab and pemetrexed maintenance in treating patients with stage
IV non-squamous non-small cell lung 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. Chemotherapy drugs,
such as pemetrexed, 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.
Carboplatin is in a class of medications known as platinum-containing compounds. It
works in a way similar to the anticancer drug cisplatin, but may be better tolerated
than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer
cells. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed
and carboplatin with or without pembrolizumab works better in treating patients with
non-squamous non-small cell cancer.
View Study Details
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.
View Study Details
CLUN21035 / S1900E / Baumgart
Lead Researcher: Megan Baumgart
This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating non-squamous
non-small cell lung cancer that is stage IV or has come back (recurrent) and has a
specific mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may
cause the cancer to grow. AMG 510, a targeted treatment against the KRAS G12C mutation,
may help stop the growth of tumor cells.
View Study Details
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. Chemotherapy drugs, 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.
View Study Details
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.
View Study Details
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 is
in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop
the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival.
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.
View Study Details
CMGIC22093 // A022104 // BADRI
Lead Researcher: Nabeel Badri
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course
chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy
drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin),
FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin
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.
FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer.
Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to
higher rates of clinical complete response (with a chance of avoiding surgery) compared
to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
View Study Details
CMGIC23011 // NRG-GI008 // Dunne
Lead Researcher: Richard Dunne
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to
patients based on the presence or absences of circulating tumor DNA (ctDNA) after
surgery for colon cancer.
View Study Details
CMGYN23001_Moore_NRG-GY026
Lead Researcher: Richard Moore
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin
HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual
chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with
HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab
are monoclonal antibodies and forms of targeted therapy that attach to specific molecules
(receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab
or pertuzumab 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.
Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in
the body longer, so that these medications will have a greater effect. Hyaluronidase
also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under
the skin and shortens their administration time compared to trastuzumab or pertuzumab
alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule
agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin
is in a class of medications known as platinum-containing compounds. It works in a
way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin.
Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving
Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink
the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial
serous carcinoma or carcinosarcoma.
View Study Details
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.
View Study Details
CMLUN23010 // S2302 // MULFORD
Lead Researcher: Deborah Mulford
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab
versus standard of care chemotherapy for the treatment of non-small cell lung cancer
that is stage IV or that has come back after a period of improvement (recurrent).
Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels
that tumors need to grow. 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 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 trial may help doctors find out if giving
ramucirumab with pembrolizumab is more effective at treating patients with stage IV
or recurrent non-small cell lung cancer than standard chemotherapy.
View Study Details
CMLYM23020 // S2114 // Reagan
Lead Researcher: Patrick Reagan
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit
patients who have received chemotherapy (fludarabine and cyclophosphamide) followed
by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene
ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has
come back (recurrent) or that does not respond to treatment (refractory) or grade
IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere
with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal
antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form
of targeted therapy because it attaches to specific molecules (receptors) on the surface
of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine
and cyclophosphamide, 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.
CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of
immune system cell) are changed in the laboratory so they will attack cancer cells.
T cells are taken from a patient's blood. Then the gene for a special receptor that
binds to a certain protein on the patient's cancer cells is added to the T cells in
the laboratory. The special receptor is called a chimeric antigen receptor. Large
numbers of the CAR T cells are grown in the laboratory and given to the patient by
infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab
vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling
or shrinking the cancer than not giving them.
View Study Details
CMMEL22099_Prieto_S2015
Lead Researcher: Eva Galka
Patients with a primary invasive melanoma are recommended to undergo excision of the
primary lesion with a wide margin. There is evidence that less radical margins of
excision may be just as safe. This is a randomised controlled trial of 1 cm versus
2 cm margin of excision of the primary lesion for adult patients with stage II primary
invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free
survival. A reduction in margins is expected to improve patient quality of life.
View Study Details
CMMMY23044 // S2209 // Lipe
Lead Researcher: Brea Lipe
This phase III trial compares three-drug induction regimens followed by double-or
single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma
in patients who are not receiving a stem cell transplant and are considered frail
or intermediate-fit based on age, comorbidities, and functional status. Treatment
for multiple myeloma includes initial treatment (induction) which is the first treatment
a patient receives for cancer followed by ongoing treatment (maintenance) which is
given after initial treatment to help keep the cancer from coming back. There are
three combinations of four different drugs being studied. Bortezomib is one of the
drugs that may stop the growth of cancer cells by blocking some of the enzymes needed
for cell growth. Lenalidomide works by helping bone marrow to produce normal blood
cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower
the body's immune response and are used with other drugs in the treatment of some
types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that
may interfere with the ability of cancer cells to grow and spread. Patients receive
1 of 3 combinations of these drugs for treatment to determine which combination of
study drugs works better to shrink and control multiple myeloma.
View Study Details
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
View Study Details
CPLEU23006 // ASCT2031 // Andolina
Lead Researcher: Jeffrey Andolina
This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using
mismatched related donors (haploidentical [haplo]) versus matched unrelated donors
(MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic
syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk
acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy
or radiation therapy, which is intended to kill cancer cells that may be resistant
to more standard doses of chemotherapy; unfortunately, this also destroys the normal
cells in the bone marrow, including stem cells. After the treatment, patients must
have a healthy supply of stem cells reintroduced or transplanted. The transplanted
cells then reestablish the blood cell production process in the bone marrow. The healthy
stem cells may come from the blood or bone marrow of a related or unrelated donor.
If patients do not have a matched related donor, doctors do not know what the next
best donor choice is or if a haplo related donor or MUD is better. This trial may
help researchers understand whether a haplo related donor or a MUD HCT for children
with acute leukemia or MDS is better or if there is no difference at all.
View Study Details
CRLUN22012 / NRG-CC009 / Milano
Lead Researcher: Michael Milano
This phase III trial compares the effect of stereotactic radiosurgery to standard
of care memantine and whole brain radiation therapy that avoids the hippocampus (the
memory zone of the brain) for the treatment of small cell lung cancer that has spread
to the brain. 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. Whole brain radiation therapy delivers a low dose of radiation to the
entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain
radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to
the hippocampus which is a brain structure that is important for memory. The drug,
memantine, is also often given with whole brain radiotherapy because it may decrease
the risk of side effects related to thinking and memory. Stereotactic radiosurgery
may decrease side effects related to memory and thinking compared to standard of care
HA-WBRT plus memantine.
View Study Details
Developing a collection of clinical, imaging and biologic specimens to identify biological
markers of Parkinson’s risk, onset and progression
Lead Researcher: Ruth Schneider
The Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) is a longitudinal, observational,
multi-center natural history study to assess progression of clinical features, digital
outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression
in study participants with manifest PD, prodromal PD, and healthy controls.
The overall goal of the study is to identify markers of disease progression for use
in
clinical trials of therapies to reduce progression of PD disability.
View Study Details
Development of Personal Choice in Adolescents
Lead Researcher: Loisa Bennetto
In this online study, a parent and their adolescent will independently complete brief
surveys. The adolescent will complete their survey first, and it may take up to 15
minutes. Afterwards, the parent will complete their survey, which may take up to 20
minutes. We hope this research will lead to expanding resources that support autonomy
and independence as adolescents transition into adulthood.
View Study Details
Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's
Milk Allergy in Children
Lead Researcher: Kirsi Jarvinen-seppo
Food allergy represents a major public health concern affecting approximately 8% of
children and 5% of adults. Cow's milk allergy is the most common food allergy in infants
and young children in developed countries. There are no validated tests for the diagnosis
of delayed onset cow's milk allergy. Patients in the Disease group will attend 6
to 7 study visits within 3 months and will have phone calls scheduled with the study
site, each for a period of 5 days. Entire Study participation will be up to 3 months.
A group of children with suspected cow's milk allergy aged from >28 days to ≤24 months
will be considered for participation in the study.
View Study Details
DRO2005 / RHAN20083 / ALTENS / Michael Cummings
Lead Researcher: Michael Cummings
The purpose of this study would like to learn if acupuncture-like electrical therapy
can be used in patients with head and neck cancer who have had radiation treatment
to treat dry mouth.
View Study Details
DRO72835 / ULUN18075 / Lung 3 vs 5 Fx SBRT / Deepinder Singh
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.
View Study Details
Dry Mouth Study
Lead Researcher: Szilvia Arany
The purpose of the study is to study dry mouth as the frequent side effect of certain
medications. Dry mouth can lead to tooth decay and cavities, damage to the gums of
your mouth, and problems with speaking and swallowing. There is not a lot known about
how certain medications can affect oral health. This study will explore how genetic
variations and certain medications play a role in the development of dry mouth. Inclusion
criteria: age between 45 and 64 years; usage of at least one medication that could
cause dry mouth
View Study Details
Dupilumab in the Treatment of Alopecia Areata Patients With an Atopic Background and/or
High IgE
Lead Researcher: Mary Gail Mercurio
Alopecia Areata is patchy baldness on the scalp. This trial will enroll patients
with moderate to severe alopecia areata (affecting more than 50% of the scalp) at
the time of screening. Potential participants must have evidence of hair regrowth
within the last 7 years of their last episode of hair loss; and have screening IgE
≥ 200 and/or have personal and/or familial history of atopy. Potential participants
will be randomized (2:1) to either receive weekly dupilumab or placebo for 48 weeks,
with all subjects completing participation through Week 48 receiving an additional
48 weeks of dupilumab (through Week 96).
View Study Details
EA2182 / RGIC19164 / DECREASE / Haoming Qiu
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.
View Study Details
EN21-PP/01 Painful Diabetic peripheral Neuropathy Study
Lead Researcher: John Markman
The University of Rochester is looking for adults 18 years and older with feet pain
from diabetes to participate in a research study about a new investigational medication.
We want to find out if it can treat foot pain from diabetes. If you are eligible,
you will be asked to: (1) come to 8-9 visits in our clinic over 3 months, (2) take
the study medication each day, and (3) answer surveys. You will be paid $85 for each
completed visit. Study related examinations and study medication will be provided
at no cost.
View Study Details
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.
View Study Details
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.
View Study Details
HEROES Study - Health Effects (Renal) Of Extra Strength Avmacol
Lead Researcher: Thu Le
This study will determine if taking a daily broccoli supplement (Avmacol ES) can decrease
kidney disease progression rate and inflammation in patients with Chronic Kidney Disease
(CKD). The study will enroll 100 patients from the Kidney Clinic in AC3 and Highland
Hospital who have CKD stages 3-4.
View Study Details
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.
View Study Details
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.
View Study Details
IBRT20063 / EF-32 / Nimish Mohile
Lead Researcher: Nimish Mohile
To test the effectiveness and safety of Optune® given concomitantly with radiation
therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation
therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide
are continued following radiation therapy.
View Study Details
IGUK21105 // MK-6482-022 // SAHASRABUDHE
Lead Researcher: Deepak Sahasrabudhe
The purpose of this study is to assess the efficacy and safety of oral belzutifan
(MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab,
in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.
The primary study hypothesis is that belzutifan plus pembrolizumab is superior to
placebo plus pembrolizumab with respect to disease-free survival (DFS).
View Study Details
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.
View Study Details
ILEU20019/20190014/ Kristen O'Dwyer
Lead Researcher: Kristen O'Dwyer
The study aims to determine the safety and feasibility of complete outpatient blinatumomab
administration for subjects with minimal/measurable residual disease (MRD) of B-precursor
Acute Lymphoblastic Leukemia (ALL).
View Study Details
ILYM20053 / KT-US-499-0150 / Reagan
Lead Researcher: Patrick Reagan
The goal of this clinical study is to learn more about the safety and dosing of the
study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory
B-cell lymphoma.
View Study Details
ILYM21068 / EONHL1-20 / Friedberg
Lead Researcher: Jonathan Friedberg
The purpose of this study is to define the recommended Phase 2 Dose, safety, tolerability,
immunogenicity, and preliminary efficacy of EO2463 during monotherapy and in combination
with lenalidomide and/or rituximab in patients with indolent NHL
View Study Details
ILYM21090 / MB106-CD20-001 / Reagan
Lead Researcher: Patrick Reagan
Study to Assess the Safety, Tolerability and Efficacy of MB-106 in Patients with Relapsed
or Refractory B-Cell NHL or CLL
View Study Details
IMLEU22004 / ASTX727-07 / Liesveld
Lead Researcher: Jane Liesveld
The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized
interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and
efficacy of ASTX727 when given in combination with venetoclax for the treatment of
newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older,
or who have comorbidities that preclude use of intensive induction chemotherapy. The
primary purpose of the study is to rule out drug-drug interactions between ASTX727
and venetoclax combination therapy by evaluating area under the curve (AUC) and maximum
plasma concentration (Cmax) exposure. The Phase 2 portion of the study is to assess
the efficacy of ASTX727 and venetoclax when given in combination and to evaluate potential
PK interactions. Phase 2 will follow the same overall study design as Phase 1 and
has two parts, Part A and Part B.
View Study Details
IMLEU22035 / CA-4948-102 / Liesveld
Lead Researcher: Jane Liesveld
This is a multicenter, open-label, Phase 1/2a dose escalation and expansion study
of orally administered emavusertib (CA-4948) monotherapy and in combination with azacitidine
or venetoclax in adult patients with Acute Myelogenous Leukemia (AML) or high risk
Myelodysplastic Syndrome (MDS).
R/R AML with FLT3 mutations, R/R including a FLT3 inhibitor
R/R AML with sliceosome mutations of SF3B1 or U2AF1
R/R hrMDS with spliceosome mutations of SF3B1 or U2AF1; bone marrow blast count >/=
8%; ineligible for intensive chemotherapy
Number of pretreatments: 1 or 2
View Study Details
IMLT19000, Turner, RPL-001-16, Solid Tumor, RP1, Nivolumab
Lead Researcher: Rachael Turner
RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study
of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or
refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended
Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
View Study Details
IMLT21110 // KT-US-982-5968 // Reagan
Lead Researcher: Patrick Reagan
The goal of this clinical study is to learn more about the long-term safety, effectiveness
and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene
autoleucel, KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants
of Kite-sponsored interventional studies.
View Study Details
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 whether CAEL-101, a monoclonal antibody
that removes AL amyloid deposits from tissues and organs, improves overall survival
and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.
View Study Details
IPNEU22061 / DAY101-002 / Korones
Lead Researcher: David Korones
This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate
the efficacy, safety, and tolerability of DAY101 monotherapy versus standard of care
(SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an
activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line
systemic therapy.
View Study Details
ISCR2201MN (Nucleix)
Lead Researcher: Michael Nead
This study is part of the development and validation of a non-invasive lung screening
test which aim to identify early stage lung cancer in patients at high risk for lung
cancer.
View Study Details
KL2TR001999 Gilmore ReFOCUS
Lead Researcher: Nikesha Gilmore
The purpose of the study is to examine the feasibility and safety of twelve weeks
oral supplementation of Epigallocatechin-3-gallate (EGCG) in older survivors of cancer
View Study Details
Longitudinal Subtyping Of Atopic Dermatitis Through Skin Analysis
Lead Researcher: Lisa Beck
This is a study which will characterize the gene expression
profiles that underlie mild and moderate-severe Atopic
dermatitis (AD). It will determine changes in these expression patterns in
response to standard-of-care treatment. Participants will complete up to ten study
visits
with assessment of topical steroid response and dupilumab response (if uncontrolled
with
topical steroids). Skin samples will be collected at all study visits to determine
the gene
expression profiles that underlie mild vs. moderate-severe atopic dermatitis.
Healthy participants without atopic dermatitis will serve as a control population
and must agree to apply a topical moisturizer (Vanicream) at least twice daily for
7 days.
Atopic dermatitis patients must have chronic AD with active lesions.
View Study Details
Lung Health Cohort
Lead Researcher: Sandhya Khurana
Because lung function reaches its peak level between the ages of 25-35 years old,
we are beginning our study with people only in this age range. If you are in this
age range and have no history of chronic (i.e. long-lasting) lung diseases - other
than mild asthma - and no history of cardiovascular disease, you may be eligible to
join this study. This study involves a combination of in-person exams (during a single
visit), at-home tasks, and remote contact (via video conference, text message, email,
phone, or mail). During the in-person visit, we will test your lung function, take
images of your chest (CT scans), and ask you to provide biospecimen samples (blood,
urine, and nasal samples). There is an at-home portion to this study where you will
wear an activity monitor for one week, and you will perform breathing tests at home.
We will follow-up with you remotely every 3 to six months (up to 4 times per year)
until the end of the study.
View Study Details
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.
View Study Details
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.
View Study Details
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.
View Study Details
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.
View Study Details
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.
View Study Details
Neuro COVID
Lead Researcher: Giovanni Schifitto
We are recruiting individuals 65 or older to learn more about how Covid impacts our
brains!
COVID is caused by a virus that enter many cells including cells of blood vessels.
This can make vessels leaky and in the brain this leakage can cause inflammation.
The damaged blood vessels are also more likely to form blood clots, causing tiny strokes.
The purpose of this study is to understand if after initial COVID infection these
leaky brain vessels fully recover or remain permanently damaged. If you decide to
take part in this study, you will be asked to come to the Clinical Research Center
(CRC) at URMC three different times: Baseline, 12 months, and 24 months - and you
will participate in two telephone calls over a 2 year period. At the baseline visit,
there is a blood draw and testing to assess your memory, attention, and movement (approximately
2.5 hours) as well as an MRI (approximately 1.5 hours). At the 12 month visit, there
is a blood draw and memory tests. At the 24 month visit, there is a blood draw, memory
testing, and an MRI.
View Study Details
NICU Antibiotics and Outcomes Trial
Lead Researcher: Carl D'angio
This study will determine if babies who receive antibiotics during the first week
of life have worse health outcomes than babies who do not receive antibiotics. The
study will enroll newborn infants born at Strong Hospital who were carried by their
mothers for 23-31 weeks before being born.
View Study Details
NRG-GU008 / RGUP20037 / INNOVATE / Hong Zhang
Lead Researcher: Hong Zhang
This phase III trial studies whether adding apalutamide to the usual treatment improves
outcome in patients with lymph node positive prostate cancer after surgery. Radiation
therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or
male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide,
may help stop or reduce the growth of prostate cancer cell growth by blocking the
attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping
the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy
and radiation therapy after surgery may stabilize prostate cancer and prevent it from
spreading and extend time without disease spreading compared to the usual approach.
View Study Details
NRG-GU009 / RGUP21002 / PREDICT-RT / Kevin Bylund
Lead Researcher: Kevin Bylund
This phase III trial compares less intense hormone therapy and radiation therapy to
usual hormone therapy and radiation therapy in treating patients with high risk prostate
cancer and low gene risk score. This trial also compares more intense hormone therapy
and radiation therapy to usual hormone therapy and radiation therapy in patients with
high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate
cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses
high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy
treatment may work the same at controlling prostate cancer compared to the usual 24
month hormone therapy treatment in patients with low gene risk score. Adding apalutamide
to the usual treatment may increase the length of time without prostate cancer spreading
as compared to the usual treatment in patients with high gene risk score.
View Study Details
NRG-GU010 / RGUP21107 / GUIDANCE / Michael Cummings
Lead Researcher: Michael Cummings
This phase III trial uses the Decipher risk score to guide intensification (for higher
Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment
to better match therapies to an individual patient's cancer aggressiveness. The Decipher
risk score evaluates a prostate cancer tumor for its potential for spreading. In patients
with low risk scores, this trial compares radiation therapy alone to the usual treatment
of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation
therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors.
Androgen deprivation therapy blocks the production or interferes with the action of
male sex hormones such as testosterone, which plays a role in prostate cancer development.
Giving radiation treatment alone may be the same as the usual approach in controlling
the cancer and preventing it from spreading, while avoiding the side effects associated
with hormonal therapy. In patients with higher Decipher gene risk, this trial compares
the addition of darolutamide to usual treatment radiation therapy and hormone therapy,
to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone)
in the tumor cells and in the body. The addition of darolutamide to the usual treatment
may better control the cancer and prevent it from spreading.
View Study Details
NRG-HN005 / CHAN19131 / Oropharyngeal Radiation Therapy / Deepinder 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.
View Study Details
NRG-HN008 / RHAN21009 / Cisplatin-Ineligible HNSCC / Michael Cummings
Lead Researcher: Michael Cummings
This phase I trial investigates the side effects and best dose of peposertib when
given together with radiation therapy in treating patients with head and neck cancer
that has spread to other places in the body (advanced) who cannot take cisplatin.
Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed
for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and
shrink tumors. This trial aims to see whether adding peposertib to radiation therapy
is safe and works well in treating patients with head and neck cancer.
View Study Details
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.
View Study Details
PASSAGE: Effectiveness of Tezepelumab, an Injectable Medication, in Treating Severe
Asthma
Lead Researcher: Steve Georas
Adult and adolescent participants may be eligible if they have severe asthma with
2 or more exacerbations in the last 12 months. The study consists of 15 in-person
visits (1 to 3 hours each). Visit 1 will be for eligibility screening. The study drug,
tezepelumab, will be given at visits 2-14. Visit 15 will be for follow-up examination.
View Study Details
PBRN00002 / ANBL00B1 / Kazi
Lead Researcher: Rafi Kazi
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.
View Study Details
PBRN18054 / ANBL1531 / Andolina
Lead Researcher: Jeffrey Andolina
This phase III trial studies iobenguane I-131 or lorlatinib 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. Lorlatinib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib
and standard therapy may work better compared to lorlatinib and standard therapy alone
in treating younger patients with neuroblastoma or ganglioneuroblastoma.
View Study Details
PBRT17119 / ACNS1422 / Korones
Lead Researcher: David Korones
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.
View Study Details
PCCB17098 / APEC1621SC / Mullen
Lead Researcher: Craig Mullen
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.
View Study Details
PCCO15102 / APEC14B1 / EveryChild Protocol / Mullen
Lead Researcher: Craig Mullen
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.
View Study Details
PGUK06001 / AREN03B2 / Mullen
Lead Researcher: Craig Mullen
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.
View Study Details
PGUK19093 / ANBL1821 / Andolina
Lead Researcher: Jeffrey Andolina
This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab
work with or without eflornithine in treating patients with neuroblastoma that has
come back (relapsed) or that isn't responding to treatment (refractory). Drugs used
in chemotherapy, such as irinotecan hydrochloride and 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. Immunotherapy with monoclonal antibodies,
such as dinutuximab, may induce changes in the body's immune system and may interfere
with the ability of tumor cells to grow and spread. Eflornithine blocks the production
of chemicals called polyamines that are important in the growth of cancer cells. Giving
eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work
better in treating patients with relapsed or refractory neuroblastoma.
View Study Details
Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive
Multiple Sclerosis
Lead Researcher: Andrew Goodman
The purpose of this study is to evaluate the safety and tolerability of ATA188 as
a
monotherapy in Parts 1 and 2, to determine the recommended Part 2 dose (RP2D) of ATA188
as
monotherapy in Part 1, and to evaluate the effect of ATA188 treatment on clinical
disability,
as assessed by sustained Expanded Disability Status Scale (EDSS) improvement at 12
months in
Part 2 in participants with progressive forms of multiple sclerosis (MS) (primary
progressive
multiple sclerosis [PPMS] and secondary progressive multiple sclerosis [SPMS]).
View Study Details
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.
View Study Details
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.
View Study Details
Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal
Epilepsy
Lead Researcher: Trenton Tollefson
This is a multiple site, randomized, double blinded parallel-group controlled study.
The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated,
daily sessions with the STARSTIM device, which delivers transcranial cathodal direct
current stimulation (tDCS). Subjects will be assigned to receive treatment with either
STARTSTIM or a sham device for 10 sessions over a 2-week period. The subjects will
be followed for an additional 10 weeks post treatment. Quality of Life questionnaires
and adverse events will be collected and evaluated.
View Study Details
PLEU18029 / AALL1631 / Mullen
Lead Researcher: Craig Mullen
This randomized phase III trial studies how well imatinib mesylate works in combination
with two different chemotherapy regimens in treating patients with newly diagnosed
Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate
has been shown to improve outcomes in children and adolescents with Philadelphia chromosome
positive (Ph+) ALL when given with strong chemotherapy, but the combination has many
side effects. This trial is testing whether a different chemotherapy regimen may work
as well as the stronger one but have fewer side effects when given with imatinib.
The trial is also testing how well the combination of chemotherapy and imatinib works
in another group of patients with a type of ALL that is similar to Ph+ ALL. This type
of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+
ALL, is thought it will respond well to the combination of agents used to treat Ph+
ALL.
View Study Details
PLEU19175 / AALL1732 / Mullen
Lead Researcher: Craig Mullen
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 or calaspargase pegol 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.
View Study Details
PLEU20095 / AAML1831 / Mullen
Lead Researcher: Craig Mullen
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated
daunorubicin-cytarabine (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.
View Study Details
PLEU21111 / APAL2020SC / Mullen
Lead Researcher: Craig Mullen
This study aims to use clinical and biological characteristics of acute leukemias
to screen for patient eligibility for available pediatric leukemia sub-trials. Testing
bone marrow and blood from patients with leukemia that has come back after treatment
or is difficult to treat may provide information about the patient's leukemia that
is important when deciding how to best treat it, and may help doctors find better
ways to diagnose and treat leukemia in children, adolescents, and young adults.
View Study Details
PMLT12010 / ALTE05N1 / Mullen
Lead Researcher: Craig Mullen
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.
View Study Details
PMLT18041 / AGCT1531 / Andolina
Lead Researcher: Jeffrey Andolina
This phase III trial studies how well active surveillance help doctors to monitor
subjects with low risk germ cell tumors for recurrence after their tumor is removed.
When the germ cell tumors has spread outside of the organ in which it developed, it
is considered metastatic. 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. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy
to use in treating metastatic standard risk germ cell tumors.
View Study Details
PMLT21052 / APEC1621A / Mullen
Lead Researcher: Craig Mullen
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 may have spread from where it first started to nearby tissue, lymph nodes,
or distant parts of the body (advanced) and have come back (relapased) or does not
respond to treatment (refractory). Larotrectinib may stop the growth of cancer cells
by blocking some of the enzymes needed for cell growth.
View Study Details
PMLT21061 / APEC1621K / Mullen
Lead Researcher: Craig Mullen
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.
View Study Details
PMLT21062 / APEC1621M / Mullen
Lead Researcher: Craig Mullen
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.
View Study Details
PMLT21063 / APEC1621N / Mullen
Lead Researcher: Craig Mullen
This phase II pediatric MATCH treatment trial studies how well selpercatinib works
in treating patients with solid tumors that may have spread from where they first
started to nearby tissue, lymph nodes, or distant parts of the body (advanced), lymphomas,
or histiocytic disorders that have activating RET gene alterations. Selpercatinib
may block the growth of cancer cells that have specific genetic changes in an important
signaling pathway (called the RET pathway) and may reduce tumor size.
View Study Details
PRG Contact Database
Lead Researcher: Brian Keane
This future contact database will facilitate contact with prospective subjects, giving
them greater opportunities to participate in behavioral and neuroimaging studies for
which they may be eligible.
View Study Details
Puerto Rican Parent-Child Feeding Interactions Study
Lead Researcher: Susan Groth
Parents will be asked to complete a series of surveys in Spanish that include questions
about their cultural values, parenting style, and feeding practices. We will also
ask questions about their feeding interactions with their child and collect height,
weight, and waist circumference measurements for both parent and child. Eligibility:
1) Identify as a Puerto Rican parent; 2) Have a 2-5-year-old child; 3) Be the child’s
primary caregiver; 4) Be responsible for feeding this child; 5) Be fluent in Spanish
View Study Details
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.
View Study Details
RGUP21115 / NRG-GU011 / PROMETHEAN / Zhang
Lead Researcher: Hong Zhang
This phase II trial tests whether relugolix and radiation therapy works to shrink
tumors in patients with prostate cancer that has spread in a limited way to 1 to 5
other parts of the body (oligometastatic). Testosterone can cause the growth of prostate
cancer cells. Relugolix lowers the amount of testosterone made by the body. This may
help stop the growth of tumor cells that need testosterone to grow. Giving relugolix
with radiation therapy may help lower the chance of prostate cancer growing or spreading.
View Study Details
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.
View Study Details
S1806 / RGUB19120 / Atezolizumab in Localized Muscle Invasive Bladder Cancer / Michael
Cummings
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.
View Study Details
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.
View Study Details
SGIP21027 / Semaphorin 4D / Mulkerin
Lead Researcher: Daniel Mulkerin
This trial will assess the safety and tolerability of Pepinemab in combination with
Avelumab in patients with metastatic pancreatic adenocarcinoma that has progressed
after first line chemotherapy. Phase 2 will assess the efficacy of this combination
therapy.
View Study Details
Spoken Language Comprehension in Adolescents
Lead Researcher: Loisa Bennetto
In this online study, an adolescent will schedule a Zoom appointment with a researcher
and complete a computer-based listening study that may take up to 45 minutes. The
parent will then complete background information surveys, which may take up to 20
minutes. Participants will be compensated via an electronic gift card. We hope that
this research will lead to a better understanding of everyday spoken language communication
and social interactions in adolescents with and without autism.
We are currently recruiting adolescents aged 13-17 without autism.
Please make sure to add an email address so that we can contact you!
View Study Details
Staccato Alprazolam as rescue medication for adolescents with epilepsy
Lead Researcher: Thomas Wychowski
After a screening visit, subjects between the age of 12-17 would be admitted to the
Clinical Research Center for 36 hours. During their admission, they would receive
a single dose of alprazolam by inhaling the medication into their lungs. They would
be observed for 36 hours with 6 sets of vital signs and blood draws. Eligibility:
Adolescents with epilepsy (either focal and/or generalized), ages 12-17, who weigh
below 110 lbs and who are in generally good health. Potential subjects must currently
be taking at least one medication for their epilepsy.
View Study Details
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.
View Study Details
Study of the Families Moving Forward Website Behavioral Intervention for Teachers
of Students With Fetal Alcohol Spectrum Disorder
Lead Researcher: Christie Petrenko
The purpose of this study is to find out if the FMF Connect Teacher Companion website
is
acceptable and usable by teachers. The FMF Connect Teacher Companion website is a
website for
teachers adapted from the Families Moving Forward (FMF) Program. The FMF Program is
an
evidence-based intervention for caregivers of children with FASD. The study will determine
if
the a web page intervention is feasible and acceptable by looking at enrollment and
retention
of study subjects and acceptability of assessments. To be eligible you must: Be an
educational professional currently actively employed in a school setting in the
United States, Be above the age of 18 years old, Have direct, consistent contact with
a student with a diagnosed fetal alcohol spectrum
disorder (FASD) or confirmed prenatal alcohol exposure (PAE) between the ages of 5-12,
(i.e. grades K to 5) in a special or general education classroom, Have reliable access
to the Internet, Be able to provide consent for yourself and speak English.
View Study Details
SWAT BE
Lead Researcher: Vivek Kaul
The purpose of this research study is to learn about the best approach to sample patients
with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle
biopsy protocol to sampling using wide area transepithelial sampling (WATS3D).
Barrett's esophagus is a common condition that is used to spot patients at increased
risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal
adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal
adenocarcinoma, but the rate may be improved if the cancer is caught in its early
stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which
occurs when cells look abnormal but have not developed into cancer. If the abnormal
cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal
(high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma)
goes up. Therefore, catching dysplasia early is very important to prevent cancer.
Endoscopic surveillance is a type of procedure where endoscopists run a tube with
a light and a camera on the end of it down a patients throat and remove a small piece
of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a
ball-point pen and is checked for abnormal cells and cancer cells.
Patients are being asked to be in this research study because they have been diagnosed
with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD).
Patients with BE undergo sampling using the Seattle biopsy protocol during which samples
are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies
from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes
brushings from the BE.
While both of these procedures are widely accepted approaches to sampling patients
with BE during endoscopy, there is not enough research to show if one is better than
the other.
Participants in this study will undergo sampling of the BE using both approaches (Seattle
biopsy protocol and WATS-3D); the order of the techniques will be randomized.
Up to 2700 participants will take part in this research. This is a multicenter study
involving several academic, community and private hospitals around the country.
View Study Details
Text Messaging Program to Support Latino Young Adults in Quitting Vaping
Lead Researcher: Francisco Cartujano
All participants will receive a 12-week text messaging intervention. Participants
will be asked to complete a baseline survey and a follow-up survey 3 months after
enrollment. Eligible individuals self-identify as Latino, are 18-25 years old, and
currently use electronic cigarettes. An active cellphone with unlimited text messaging
capability is required to participate.
View Study Details
The CHRONICLE Study - Comparing Standard Treatments for Severe Asthma
Lead Researcher: Steve Georas
In this study, you will complete monthly surveys (12 per year) about your life and
health via a dedicated web site. The first survey package will take about 45 minutes
to complete. Afterward, most monthly surveys will be short and require about 5-10
minutes to complete. In addition to these brief surveys, there will be longer surveys
every 3 months that will require an additional 15-30 minutes to complete. You can
expect to complete surveys for up to 5 years over the duration of the study. When
you first join the study - as well as every 6 months after - we will ask your doctor
to report information about your past/current health status and clinical observations.
Eligibility: Must have severe, uncontrolled asthma, seeing a pulmonologist or allergist
at the study doctor's site, and be on high-dose inhaled therapy or on a monoclonal
antibody therapy for asthma.
View Study Details
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.
View Study Details
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.
View Study Details
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.
View Study Details
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.
View Study Details
UBMT15029 / 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.
View Study Details
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).
View Study Details
UBRS20139 / FACT-5 / Ajay Dhakal
Lead Researcher: Ajay Dhakal
The purpose of this research is to look at the safety and effectiveness of a HER2-targeted
therapy neratinib when given with capecitabine, a chemotherapy, for breast cancer
patients with brain metastases whose tumors were HER2-negative by standard tests but
showed abnormal HER2 activity based on the CELsignia results.
View Study Details
UBRS20152 / BTCRC BRE15-024 / O'Regan
Lead Researcher: Ruth O'Regan
This is an open label, multi-institutional, single arm phase II trial of ribociclib
in combination with bicalutamide in advanced AR+ triple-negative breast cancer. No
randomization or blinding is involved.
View Study Details
UBRS21032 / HCRN-BRE17-141 / O'Regan
Lead Researcher: Ruth O'Regan
Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for
24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase
inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast
biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery,
patients will receive standard of care HER2-directed and endocrine therapy at the
treating physician's discretion.
View Study Details
UBRT21040 / Early START / Sara Hardy
Lead Researcher: Sara Hardy
High grade gliomas (HGGs) are rapidly progressive brain tumors resulting in death
for most patients between 6 months and 2 years after diagnosis. It is important for
patients with HGG to discuss and document their wishes at the end of life. However,
many of these patients experience early changes in cognition which impede their decision-making.
For this reason, these patients should have early discussions with their providers.
However, implementation of this remains challenging in clinical practice.
In this study, we will create an Early STructured Advanced care Referrals by Telehealth
(Early START) visit for patients soon after their initial oncology visit. A checklist
and pre-visit guide were developed to help guide the visit for both the provider and
patient. Providers will receive special training in running these visits. Caregivers
and/or family members will be encouraged to participate. Visits will be done using
video or telephone and recorded. For patients who do not have access to technology
for these visits, it will be provided. After the visit, patients, caregivers and/or
family who participated, and providers will fill out surveys to address feasibility
of having these extra visits and improve the visits for future. Patients will be followed
until death. Caregivers and/or family who participated will be asked about whether
end of life was in line with the patient's wishes. We will also use the patient's
medical record to assess other aspects of end of life. We will compare end of life
outcomes with other similar patients treated at our center.
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UBRT21074 / BRV / Wychowski
Lead Researcher: Thomas Wychowski
The purpose of this study is to determine whether the study medication, brivaracetam,
is tolerable and safe for patients with brain tumors.
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UCCP21048/ Text Base Colorectal Cancer Screening/ Abar, Adler, Fiscella
Lead Researcher: Beau Abar
In this project, we intend to conduct a randomized pilot trial of a structured behavioral
intervention, grounded in the Theory of Planned Behavior and Self-Determination Theory,
to promote adherence of patients aged 45 - 75 to USPSTF colorectal cancer screening
recommendations. We will also collect qualitative feedback on perceptions of the intervention
to inform its refinement.
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UCCP21070 / Uptake / Adler
Lead Researcher: David Adler
This is a randomized controlled pilot trial of a text-based behavioral intervention
aimed at increasing uptake of lung cancer screening among emergency department patients.
We will conduct a 2-year randomized controlled clinical trial with a prospectively
collected convenience sample of 366 adults who are eligible for LCS but non-adherent
with LCS screening guidelines. Adults aged 50-80 will be recruited from a high-volume
urban ED and a low-volume rural ED, assigned to study conditions, and followed-up
at 150 days to assess interval engagement with the University of Rochester Medical
Center's LCS screening program (primary outcome). Electronic Health Record (EHR) review
will be conducted to assess screening results and subsequent clinical endpoints.
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UCCS19102 / MAAT-G JIT (Breast) / Magnuson
Lead Researcher: Allison Magnuson
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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UCCS20127 / MAAT-G Phase II / Magnuson
Lead Researcher: Allison Magnuson
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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UCCS21043 / RCT mHealth Exercise Intervention / Loh
Lead Researcher: Kah poh Loh
This is a phase 2 randomized controlled trial (RCT) to assess the preliminary efficacy
of the a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education
control in 100 older patients with MN receiving outpatient chemotherapy on physical
function and patient-reported outcomes (fatigue, mood, and quality of life). We will
also explore the effect of the intervention on TNFα and related cytokine gene promoter
methylation and their gene and protein expression.
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UCCS21065 / Dyadic Life Review / Lee Kehoe
Lead Researcher: Lee Kehoe
The purpose of this study is to test the feasibility of a telehealth Dyadic Life Review
(DLR), adapted from individual Life Review Therapy, with caregivers of older adults
with advanced cancer, including those with Mild Cognitive Impairment (MCI). The study
will enroll 20 dyads of caregivers and older patients with advanced cancer and 20
dyads of caregivers and patients with advanced cancer and Mild Cognitive Impairment
(MCI).
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UCCS21067 / OACS / Kadambi
Lead Researcher: Sindhuja Kadambi
This project assesses the feasibility of utilizing the geriatric assessment as a tool
to identify distressed older caregivers of older adults with cancer. The investigator
will engage key stakeholders including older caregivers of older adults with cancer,
experts in geriatric oncology and primary care physicians to develop and pilot a supportive
care intervention to improve outcomes in older caregivers.
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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, Guercio, HCRN GU18-343, Urinary Bladder Neoplasms, Cabozantinib, Atezolizumab
Lead Researcher: Brendan Guercio
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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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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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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ULAB21028 / LEO / Friedberg
Lead Researcher: Jonathan Friedberg
The goal of this infrastructure protocol is to build and maintain a large and diverse
observational cohort study to support broad and cutting-edge research focused on NHL
prognosis and survivorship. The LEO cohort will promote identification of clinical
(including co-morbid diseases), epidemiologic (including lifestyle and other exposures),
host genetic, tumor, and treatment factors that impact multiple outcomes (including
event-free, overall and lymphoma-specific survival; new onset comorbidities; and patient-reported
outcomes). This resource also will allow examination of the interaction among these
factors in order to better understand the clinical and molecular epidemiology of outcomes
in NHL. Ultimately, this approach will drive discovery and validation of treatment
endpoints, improve prognostication, and identify novel approaches to improve short
and long-term outcomes for NHL patients.
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ULEU07047 / RSRB20123 / Michael Becker
Lead Researcher: Jane Liesveld
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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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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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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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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UMLT20123 / Van Veldhuizen / SMM & Prostate
Lead Researcher: Peter Van Veldhuizen
To explore the use of curcumin and piperine supplementation at a dose of 4 gram/5mg
twice a day in early stage prostate cancer patient undergoing active surveillance
or patients on observation for MGUS/ low-risk smoldering myeloma.
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UMMMY22027 // Selinexor // Lipe
Lead Researcher: Brea Lipe
Selinexor is a drug that has been approved in the treatment of patients with symptomatic
multiple myeloma. The standard of care for patients with Smoldering Multiple Myeloma
remains observation, but there are numerous clinical trials investigating interventions
to delay progression to multiple myeloma and prevent or delay disease related outcomes.
A subset of patients with intermediate or high risk smoldering multiple myeloma have
a much higher risk of progressive to multiple myeloma, while the low risk smoldering
myeloma patient population has a much lower risk. This is a clinical trial investigating
the use of low-dose selinexor in patients with intermediate to high-risk smoldering
multiple myeloma. The investigators hypothesize that the use of selinexor in intermediate
to high risk smoldering myeloma patients will help to delay progression of disease
to symptomatic multiple myeloma.
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UMMY19160/Hyperbaric Oxygen/ Omar Aljitawi
Lead Researcher: Omar Aljitawi
Subjects with multiple myeloma (MM) who are considered eligible for high-dose therapy
and autologous stem cell transplantation by the transplant team at WCI will be enrolled
in the study.
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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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UOCPC22008 / Triadic / Magnuson
Lead Researcher: Allison Magnuson
To gather key stakeholder input for feedback on the adaption of the COACH GA intervention
(i.e., develop COACH-Cog) to enhance triadic communication among oncologists, care
partners and patients with ADRD.
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UOCPC22010 / UR-GOAL 2 / Kah Poh Loh
Lead Researcher: Jason Mendler
The objective of this study is to conduct a pilot randomized trial to evaluate the
preliminary efficacy of the UR-GOAL tool vs. usual care in improving shared decision
making and communication between 100 older patients with AML and their oncologists.
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UOCPC22022 / E-Co Study / Kah Poh Loh
Lead Researcher: Kah poh Loh
The objective of the study is to evaluate the feasibility of a combined mobile health
exercise and cognitive rehabilitation intervention and its effect on cognition in
a single-arm pilot study that recruits cancer survivors.
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UOCPC22039 / Inpatient SICP / Loh
Lead Researcher: Jason Mendler
This is a pilot study to assess the preliminary efficacy of an inpatient advance care
planning intervention on outcomes in older patients with hematologic malignancies
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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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VAPOR 2 Study Pivotal Study Clinical Protocol/Frye/IUGUP23019
Lead Researcher: Thomas Frye
The purpose of this study is to evaluate the safety and efficacy of the Vanquish Water
Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2
(GGG2) localized intermediate-risk prostate cancer.
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