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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07764744
Status
Not Yet Recruiting

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Conditions

  • BRCA 1 Gene Mutation
  • BRCA 2 Gene Mutation
  • Early Detection of Ovarian Cancer
  • Ovarian Neoplasms
  • Serous Tubal Intraepithelial Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
35 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Galleri Multi-Cancer Early Detection (MCED) Blood Test — DEVICE
    Participants will undergo blood collection for the Galleri multi-cancer early detection (MCED) test, an investigational in vitro diagnostic device performed in a CLIA-certified laboratory. Results will be evaluated for feasibility, acceptability, and exploratory diagnostic performance for early detection of epithelial ovarian cancer in high-risk individuals.

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2039
Completion
Jul 31, 2039

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort A: BRCA1/2 Surgical Feasibility Cohort
    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.
  • Experimental: Cohort B: STIC Longitudinal Surveillance Cohort
    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.

Primary Outcome Measure

Feasibility of Galleri testing in BRCA1/2 surgical cohort A [ Time Frame: Day of surgery (up to 1 day) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Melissa K Frey, MD, MS
[email protected]
646-697-6621
Melissa K Frey, MD, MS (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Jose A Rauh-Hain, MD
[email protected]
713-392-6161
Jose A Rauh-Hain, MD, MS (PRINCIPAL_INVESTIGATOR)

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