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

Not Yet RecruitingNA

Sponsor: Weill Medical College of Cornell University

Conditions: Ovarian Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Serous Tubal Intraepithelial Carcinoma, Early Detection of Ovarian Cancer

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

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 35 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (2)

New York, New York, United States
Houston, Texas, United States