Clinical Trial

Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants

Study acronym: OC-LEAD
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07764744
Lead Sponsor Weill Medical College of Cornell University
Collaborators: M.D. Anderson Cancer Center
Conditions Ovarian Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Serous Tubal Intraepithelial Carcinoma, Early Detection of Ovarian Cancer
Enrollment 70 participants
Start Date 2026-08
Primary Completion 2039-07 (estimated)
Study Completion 2039-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-14