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

NCT07764744 | Not Yet Recruiting FDA Device

• 1 other identifier: 26-02029818
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Ovarian cancer; Liquid biopsy; Galleri; Multi-cancer early detection; BRCA1; BRCA2; Hereditary breast and ovarian cancer syndrome; Serous tubal intraepithelial carcinoma (STIC); Risk-reducing salpingo-oophorectomy; Early cancer detection; Hereditary cancer; Cancer screening; Implementation science

Outcome Measures

Primary Outcomes (2)

• Feasibility of Galleri testing in BRCA1/2 surgical cohort A

  Proportion of eligible BRCA1/2 PV patients in Cohort A who successfully complete liquid biopsy testing day of risk-reducing gynecologic surgery, with corresponding surgical pathology available for correlation.

  Day of surgery (up to 1 day)

• Feasibility of annual Galleri testing in STIC cohort B

  Proportion of Cohort B patients who continue with annual liquid biopsy following diagnosis of STIC lesion for 10 years following STIC lesion diagnosis

  Up to 10 years

Secondary Outcomes (24)

• Participant-Reported Perceptions Regarding Liquid Biopsy

  One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.

• Participant-Reported Barriers Regarding Liquid Biopsy

  One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.

• Participant-Reported Facilitators Regarding Liquid Biopsy

  One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.

• Participant-Reported Acceptability Regarding Liquid Biopsy

  One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.

• Participant-Reported Trust Regarding Liquid Biopsy

  One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.

Study Arms (2)

Cohort A: BRCA1/2 Surgical Feasibility Cohort

EXPERIMENTAL

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.

Device: Galleri Multi-Cancer Early Detection (MCED) Blood Test

Cohort B: STIC Longitudinal Surveillance Cohort

EXPERIMENTAL

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.

Device: Galleri Multi-Cancer Early Detection (MCED) Blood Test

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.

Cohort A: BRCA1/2 Surgical Feasibility Cohort; Cohort B: STIC Longitudinal Surveillance Cohort

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort A participants must meet all of the following criteria:
• Age ≥ 35 years (based on current National Comprehensive Cancer Network guidelines35 for risk-reducing gynecologic surgery) with no upper age limit
• Confirmed germline PV or likely PV in the BRCA1 or BRCA2 genes, documented by CLIA-certified genetic testing.
• Scheduled to undergo risk-reducing gynecologic surgery (salpingo-oophorectomy or salpingectomy with or without hysterectomy) at the study site.
• 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:
• Age ≥ 35 years with no upper age limit.
• STIC lesion previously identified on surgical pathology within the prior 10 years.
• Willing and able to undergo baseline and annual research blood draws for up to 10 years following STIC lesion diagnosis.
• Willing and able to provide informed consent in English

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (2)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Neoplasms; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Melissa K Frey, MD, MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa K Frey, Study Official, MD, MS

CONTACT

646-697-6621; mkf2002@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-group, prospective, multi-center study in which all participants receive the Galleri multi-cancer early detection blood test. Participants are enrolled into one of two predefined cohorts based on clinical characteristics: (1) BRCA1/2 pathogenic variant carriers undergoing risk-reducing gynecologic surgery or (2) individuals with a prior diagnosis of serous tubal intraepithelial carcinoma (STIC) undergoing longitudinal surveillance. There is no randomization or comparator arm. Liquid biopsy results will be correlated with surgical pathology and/or longitudinal clinical outcomes, and a subset of participants will complete qualitative interviews.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2039
• Study Completion (Estimated): July 1, 2039
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)