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

NCT07764744 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Galleri Multi-Cancer Early Detection (MCED) Blood Test

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Melissa K Frey, MD, MS · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2039-07-31
Completion
2039-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764744 on ClinicalTrials.gov