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

Official record

Identifier

NCT07764744

Recruiting locations

country

United States

Interventions studied

Galleri Multi-Cancer Early Detection (MCED) Blood Test

Lead sponsor

Weill Medical College of Cornell University

Target enrolment

70 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Not yet recruiting

First posted

Aug 14, 2026

Last updated on the registry

Sep 11, 2026

Age

35 Years

Sex

FEMALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

Cohort A participants must meet all of the following criteria:

1. Age ≥ 35 years (based on current National Comprehensive Cancer Network guidelines35 for risk-reducing gynecologic surgery) with no upper age limit
2. Confirmed germline PV or likely PV in the BRCA1 or BRCA2 genes, documented by CLIA-certified genetic testing.
3. Scheduled to undergo risk-reducing gynecologic surgery (salpingo-oophorectomy or salpingectomy with or without hysterectomy) at the study site.
4. Willing and able to provide informed consent in English This initial phase is limited to English-speaking participants. This limitation is due to feasibility considerations for initial qualitative instrument validation; future phases will incorporate translated materials

   Cohort B participants must meet all of the following criteria:
5. Age ≥ 35 years with no upper age limit.
6. STIC lesion previously identified on surgical pathology within the prior 10 years.
7. Willing and able to undergo baseline and annual research blood draws for up to 10 years following STIC lesion diagnosis.
8. Willing and able to provide informed consent in English

Exclusion Criteria:

Cohort A:

1. Pregnant or breastfeeding at the time of enrollment.
2. Prior removal of bilateral fallopian tubes and/or bilateral ovaries.
3. Active diagnosis of cancer.
4. Prior or active diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer at the time of consent.
5. Patients with a history of cancer are eligible when \> 2 years no evidence of disease.
6. Inability to provide informed consent.
7. Concurrent participation in another interventional trial that may confound study outcomes.

Cohort B:

1. Pregnant or breastfeeding at the time of enrollment.
2. Active diagnosis of cancer.
3. Prior or active diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer at the time of consent (prior STIC lesion is NOT a contraindication to enrollment).
4. Patients with a history of cancer are eligible when \> 2 years no evidence of disease.
5. Inability to provide informed consent.
6. Concurrent participation in another interventional trial that may confound study outcomes.

Indexed under

Breast Cancer