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

Study acronym: OC-LEAD
StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Jul 2039 → Oct 2039
See other at-risk trials from Weill Medical College of Cornell University

Record History

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  1. Primary endpoints: details revised at 1 of 2 entries Show 5 more changesShow less
    • Primary and study completion pushed from Jul 2039 to Oct 2039
    • Start date pushed from Sep 2026 to Oct 2026
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 7 of 24 entries
    • Study description revised
  2. Start date: Aug 2026 to Sep 2026v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
(from sponsor)		 Ovarian Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Serous Tubal Intraepithelial Carcinoma, Early Detection of Ovarian Cancer
Related terms Hereditary Breast and Ovarian Cancer Syndrome, Ovarian Neoplasms
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov