Ovarian cancer risk model for family members with BRCA mutations
Official title: Development and Validation of an Ovarian Cancer Risk Prediction Model for Family Members of Ovarian Cancer Probands With BRCA1/2 Germline Mutations
Run by Peking University Third Hospital · NCT07039552 · Data updated 2026-11-12
This project will try to build and validate a tool to predict ovarian cancer risk for adults who carry BRCA1/2 mutations and their close family members.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 10000 (estimated) |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2016 |
| Main results expected | December 30, 2028 |
| Study ends | December 30, 2035 |
| Registry record updated | June 26, 2025 |
| Trial ID | NCT07039552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are carriers of pathogenic or likely pathogenic BRCA1/2 germline mutations or close family members of ovarian cancer probands and who consent to participate are ideal candidates.
✕Probably not a fit
People without BRCA1/2 mutations, those unwilling or unable to provide required information or follow-up, and those already diagnosed and treated for ovarian cancer may not benefit from the predictive model.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter ambispective cohort study will collect clinical, family, genetic, and lifestyle data from people with pathogenic or likely pathogenic BRCA1/2 germline mutations and their relatives. Researchers will combine historical records and prospective follow-up to track ovarian cancer incidence, including annual telephone follow-up for unaffected family members to gather diagnostic evidence. Information about risk-reducing salpingo-oophorectomy (RRSO) and other interventions will be recorded to understand their impact on observed risk. The goal is to develop and validate a risk prediction model tailored to the Chinese population.
Why it matters
Potential benefit: If successful, the model could help identify higher-risk relatives earlier so they can receive targeted surveillance or preventive options to reduce late-stage diagnoses.
How similar studies have gone: Similar BRCA-based risk models (e.g., BRCAPRO, BOADICEA) have been used successfully in Western cohorts, but few models have been developed or validated specifically for Chinese BRCA carriers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Pathologically diagnosed with ovarian malignant tumor.
* Identified as carriers of BRCA1/2 germline pathogenic or likely pathogenic mutations through genetic testing, in accordance with the "Standards and Guidelines for the Interpretation of Sequence Variants" (2015 Edition) of the American College of Medical Genetics and Genomics (ACMG).
* Age of 18 years or older. ④ Voluntary participation in this research and signing of the informed consent form.
Exclusion Criteria:
* ① Patients who refuse to provide necessary information.
Where it's running
-
Peking University Third Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Yuan Li
- Email: yuanli@bjmu.edu.cn
- Phone: 18610689868
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.