Galleri Blood Test for Ovarian Cancer
(OC-LEAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical study is to evaluate the feasibility and acceptability of the Galleri multi-cancer early detection blood test in people with BRCA1 or BRCA2 gene changes who are at high risk for ovarian cancer. The study will also explore how well the test detects ovarian cancer or related precancerous conditions.
The main questions it aims to answer are:
* Is it feasible to incorporate the Galleri blood test into the care of people at high \* risk for ovarian cancer?
* Is the Galleri blood test acceptable to participants?
* How well does the Galleri blood test identify ovarian cancer or related precancerous conditions?
Participants will:
* Receive the Galleri blood test.
* Complete questionnaires about their experience with the test.
* Some participants will also complete an interview about their experiences and preferences.
* Continue with their planned standard medical care, including surgery or follow-up visits, as appropriate.
Who Is on the Research Team?
Melissa K Frey, MD, MS
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for people with BRCA1 or BRCA2 gene mutations who are at high risk for ovarian cancer. Participants should be able to give a blood sample and complete questionnaires about their experience.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Testing
Participants receive the Galleri multi-cancer early detection blood test at baseline
Surgical Feasibility
Participants in Cohort A undergo risk-reducing gynecologic surgery and receive the Galleri blood test on the day of surgery
Longitudinal Surveillance
Participants in Cohort B undergo annual Galleri blood testing for up to 10 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Galleri Multi-Cancer Early Detection (MCED) Blood Test
Trial Overview
The study is testing the Galleri multi-cancer early detection (MCED) blood test to see if it can help find ovarian cancer or related conditions early in people at high genetic risk. Participants will also share feedback on their experience with the test.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Cohort B: Participants with a prior diagnosis of serous tubal intraepithelial carcinoma (STIC) who receive the Galleri multi-cancer early detection blood test at baseline and annually for up to 10 years as part of longitudinal surveillance.
Cohort A: Participants with pathogenic or likely pathogenic BRCA1/2 variants undergoing planned risk-reducing gynecologic surgery who receive the Galleri multi-cancer early detection blood test on the day of surgery. Liquid biopsy results will be correlated with surgical pathology findings.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
M.D. Anderson Cancer Center
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.