Clinical Research & Trials
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.
Search Clinical Trials and Research Studies
View All Clinical StudiesAn 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. People between the ages of 18-55 with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or no psychiatric diagnosis may be eligible to participate.
BABE
Lead Researcher: Kirsi Jarvinen-seppo
You are eligible if you are pregnant and 18 years old or older and give birth to a healthy infant. The purpose of this study is to compare a group of people at low risk for getting allergies, the Old Order Mennonite, with a group of people at higher risk of getting allergies, the average person living in Rochester. The immune system protects us from diseases, working throughout the body, including in secretions such as saliva and breast milk, and in the normal bacteria in the stomach and intestines. The way people live, including the things they are exposed to, changes the way the immune system develops. A baby’s immune system develops over time. The baby’s ability to fight disease is helped by the mom’s immunity passed to the baby through breast milk. By comparing biological samples like saliva, breast milk, and stool, we can study differences between these two groups to see what’s different in a group at low risk and a group at higher risk of getting allergies. Using questionnaires and biologic samples (stool, skin cells, blood, etc.) we will evaluate the development of the infant microbiome, metabolite composition and the immune system and how that relates to the development of allergic disease. The microbiome is the collection of all microbes, such as bacteria, fungi, viruses, and their genes, that naturally live on our bodies and inside us. A metabolite is any substance produced during metabolism (digestion or other bodily chemical processes). The term metabolite may also refer to the product that remains after a medicine is broken down (metabolized) by the body.
BEGIN - A Breastfeeding Study
Lead Researcher: Bridget Young
We are looking for: - Mothers who are exclusively pumping for babies under 5 weeks old - Participation will last until your baby is 5 months old - We will have you collect breastmilk, stool, urine, and saliva at home - This study is totally remote – no need to ever leave your house! Earn $100/month & receive breastfeeding support from our team!
CBMT11074 / NMDP 10-CBA / Omar Aljitawi, MBBS (previous PI-Jane Liesveld, MD)
Lead Researcher: Omar Aljitawi
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.
CGIP20087 / A021806 / Daniel Mulkerin
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).
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.
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.
Connection in Caregivers
Lead Researcher: Kimberly Van orden
Subjects will complete a baseline interview (phone/zoom and online) at the beginning of the study. If eligible, subjects will complete 10 days of surveys that are texted 3 times a day (morning, afternoon, evening). Eligible subjects will also complete a follow-up interview (zoom/phone and online) at 6 months. Subjects are paid up to $250 for completing assessments. Inclusion: age 50 and older; caring daily for a loved one with dementia; caregiving stress. Exclusion: Under 50 years of age; not caring for a loved one with dementia daily.
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
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.
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.
Fine Eye Movement Study
Lead Researcher: Brian Keane
This study will look at differences in eye movement as they relate to visual perception and the way people think. The information collected in this study will aid in finding ways to more accurately diagnose psychiatric disorders, namely schizophrenia, by using eye scans. Also, results from this study may guide the development of more tailored therapies to help people with psychiatric disorders in the future. Procedures include: interviews about your medical and drug use history; a vocabulary test; review of your eRecord data; visual perceptual tasks completed on a computer; and eye scans (like those during an eye doctor exam). Some of these procedures may occur via Zoom, depending on participant preferences. Eligibility: Ages 18-55; a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder OR no psychiatric disorder with no more than one lifetime major depressive episode.
Intellectual & Developmental Disabilities Research Center Contact Registry
Lead Researcher: Alexander Paciorkowski
The University of Rochester's Intellectual & Developmental Disabilities Research Center (IDDRC) is creating a research study contact database for those with intellectual and developmental disabilities (IDDs). This will help keep people with IDDs, and their families, informed about opportunities to join research studies that can impact the way healthcare is provided, improving the health and wellbeing of those with IDDs. When you join this contact database, you may be contacted about future research study opportunities at the University of Rochester. There are a variety of studies that may be offered, and some studies may offer compensation. There is no obligation to participate in any of the future studies for which you are contacted. You can always withdraw from a research study at any time without penalty. If you have an IDD diagnosis, you can sign up to be a part of this database (it’s okay for a legal guardian to help with the sign-up if needed). Qualifying diagnoses include, but are not limited to, autism spectrum disorders, developmental delay, intellectual disability, Down syndrome, fetal alcohol spectrum disorder, cerebral palsy, MECP2 mutation (e.g., Rett Syndrome), Batten disease and Angelman syndrome.
Interactive Group Drumming and "Chemo Brain"
Lead Researcher: Gaelen Mccormick
If you decide to take part in this study, you will be asked to participate, as you are able, in four consecutive weekly drumming groups of up to ten people occurring at the same time each week, led by a professional facilitator. Each group will be one hour in length. During these groups, the facilitator will invite subjects to follow simple oral (singing and speaking) and musical instructions by playing the drums we will provide. At the beginning and the end of each session, you will be asked to answer a brief questionnaire about your state of wellbeing. At the beginning and end of the study, you will be asked to answer a survey about cognitive function (and your experience with “chemo brain”) using the FACT COG assessment survey. After the study concludes, you will be asked to answer a survey about satisfaction with your experience of the drumming session. Your participation will last about 4 weeks.
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.
Mapping Meaningful Symptoms and Impacts in People with Prodromal Parkinson’s Disease- The PPMI Mapping Meaningful Symptoms Study
Lead Researcher: Jamie Adams
The goal of this study is to talk to people and gather information about symptoms related to Parkinson's Disease and Lewy Body Dementia. We will interview both healthy people and those who might be at risk for these diseases. The information we collect will help us understand the symptoms better and improve early diagnosis and care for patients with Parkinson's Disease and Lewy Body Dementia. Must be aged 60 years or older. Must be able to provide informed consent. Must be able to speak English. No significant neurologic or psychiatric disease. No diagnosis of Parkinson's Disease/parkinsonism/Lewy Body Dementia. Must be able to participate in an online interview conducted via Zoom with a tablet or computer.
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.
Observational Study of ICU Patients with Systemic Inflammatory Response Syndrome (SIRS)
Lead Researcher: Anthony Pietropaoli
This is an observational research study of subjects admitted to the ICU with severe SIRS (and/or sepsis). For ICU subjects enrolled: the study involves collecting up to 2 blood samples (3-5 days apart), data collection, and post-discharge follow-up questionnaires. For healthy volunteers: Subjects age 65 and older are needed for a one-time blood sample collection for comparison studies. A brief health questionnaire and set of vital signs will also be collected at the study visit. Volunteers must be age 65 or older and cannot be on antibiotics or antivirals for current infection. Volunteers also must not have had an infection within 6 weeks prior to the study visit.
Parent Cafe Study for Caregivers of Children with Medical Complexity
Lead Researcher: Nathaniel Bayer
We started monthly peer and emotional support group sessions for caregivers of children with medical complexity. We are looking for interested parents and caregivers to participate in our research, attend support sessions, and provide feedback to improve them. A child with medical complexity means that a child has/had 2 or more long-term diagnoses and uses/used medical devices (like a feeding tube or tracheostomy). Depending on the status and age of your child, you could either help us design the support groups, lead the support groups, or participate in the support groups as an attendee. Families with different diagnoses, outcomes, racial and ethnic backgrounds, genders, sexual orientations, religions, geographic regions and physical abilities all provide important insight and perspective. We are recruiting caregivers of children who have fully recovered, have recovered with ongoing needs, are undergoing treatment, or have passed away. Your lived experience and perspective matters.
PLEU19175 / AALL1732 / Kazi
Lead Researcher: Rafi Kazi
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, to classify patients into post-consolidation treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of delayed intensification. 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.
Povidone Iodine Study for Childhood Cavities
Lead Researcher: Dorota Kopycka-kedzierawski
This is a clinical trial to determine whether 10% Povidone Iodine prevents new cavities when applied to the teeth of children with Severe Early Childhood Caries (S-ECC). Study participants will be followed for approximately 24 months after receiving treatment. Children age 24 to 71 months with parents/guardians who are 18 or older are eligible. Children must be diagnosed with Severe-Early Childhood Caries (S-ECC) requiring treatment in the operating room.
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.
Social Connection Coaching for Adults Age 60 Years or Older
Lead Researcher: Kimberly Van orden
Adults (age 60 or older) will participate in Social Connection Coaching. This involves meeting with a Coach up to 10 times. The first 8 sessions will be completed during the first 8 weeks. A booster session will be done at 12 weeks and 16 weeks. These meetings are brief (approximately 30 mins) and will be done at a private space at your senior living community or senior center, your home or our office. The coaching is designed to help you enhance your relationships and improve well-being. Your coach will help you identify goals for improving your social relationships. Each session, your coach will help you set a goal for the week, brainstorm strategies to meet the goal, and identify concrete steps to take to achieve the goal. You would also complete research assessments by phone or zoom at study start, 8 weeks and 16 weeks. This study also involves using a study provided smartphone to complete assessments. Subjects are paid up to $500 for completing assessments.
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!
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.
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.
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).
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.
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.
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.
UGYO17017 / MD Anderson / Richard Moore
Lead Researcher: Richard Moore
The goal of this clinical research study is to evaluate a method involving 4 blood tests called CA-125, HE4, HE4 antigen autoantibody complexes, and osteopontin that may be helpful in the early detection of ovarian cancer in women who are at low risk.
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.
UOCPC22065 / SONATA / Kah Poh Loh
Lead Researcher: Kah Poh Loh
The purpose of this study is to see if a social network support program (SOcial Networks to Activate Trust \& Adherence or SONATA) is helpful for older individuals receiving cancer treatment. The SONATA program will last for about 4 months. There are a total of 6 coaching sessions. The first 5 sessions will be held approximately every 1 to 2 weeks. Session 6 or the final session will be held approximately 1 to 2 months after session 5. Each session will last for about 1 to 2 hours.