NCT07764744Not yet recruiting
Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants
Ovarian Cancer Liquid Biopsy for Early Assessment & Detection (OC-LEAD)
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 10 Aug 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2039
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Ovarian cancer
- NCT number
- NCT07764744
What you commit to
- Study type: Interventional
- Planned participants: 70
- From Oct 2026 to the primary completion date, Oct 2039
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior removal of bilateral fallopian tubes and/or bilateral ovaries.
- Prior or active diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer at the time of consent.
- Concurrent participation in another interventional trial that may confound study outcomes.
- Cohort B:
- 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).
- Concurrent participation in another interventional trial that may confound study outcomes.
Other illness
- Active diagnosis of cancer.
- Active diagnosis of cancer.
Age
- Patients with a history of cancer are eligible when \> 2 years no evidence of disease.
- Patients with a history of cancer are eligible when \> 2 years no evidence of disease.
Other
- Cohort A:
- Pregnant or breastfeeding at the time of enrollment.
- Inability to provide informed consent.
- Pregnant or breastfeeding at the time of enrollment.
- Inability to provide informed consent.
Who the study is looking for
- 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
Age in the registry: 35 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.