Preventive removal or staged removal of fallopian tubes and ovaries for women with hereditary ovarian cancer risk
A Bidirectional Cohort Study on Prophylactic Resection Surgery in Populations at Moderate-to-High Risk for Hereditary Ovarian Cancer
This project will test whether removing fallopian tubes now and delaying ovary removal, versus standard full removal or close monitoring, reduces ovarian cancer risk and preserves ovarian function in women with BRCA or similar gene changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 480 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07532434 on ClinicalTrials.gov |
What this trial studies
This bidirectional cohort combines retrospective data starting in 2020 with a prospective follow-up of at least five years to compare different prophylactic surgical paths chosen by patients and their doctors. Participants who are carriers of pathogenic or likely pathogenic variants in genes such as BRCA1/2, RAD51C/D, BRIP1, or PALB2 will be grouped by standard risk-reducing salpingo-oophorectomy (RRSO), prophylactic salpingectomy with delayed oophorectomy (PSDO), or close monitoring. Researchers will collect clinical records, surgical pathology, ovarian function measures, and quality-of-life and psychological assessments to compare cancer incidence, safety, and life impact across groups. The goal is to identify whether individualized surgical strategies can lower cancer risk while minimizing adverse effects on hormonal function and quality of life.
Who should consider this trial
Good fit: Healthy adult women (age ≥18) who carry pathogenic or likely pathogenic germline variants in high-risk ovarian cancer genes (e.g., BRCA1, BRCA2, RAD51C/D, BRIP1, PALB2) and who can provide consent and attend long-term follow-up are ideal candidates.
Not a fit: Women with prior ovarian, fallopian tube, or primary peritoneal cancer, those with synchronous advanced malignancies, or those unable to complete required follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower ovarian cancer risk while preserving ovarian function and quality of life for some high-risk women.
How similar studies have performed: Prior biological and early clinical work supports removing fallopian tubes as a way to lower some ovarian cancer risk, but long-term comparative outcome data for staged approaches like PSDO remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gender: Female. Age: 18 years or older at the time of enrollment.Genetic Risk: Documented carriers of pathogenic or likely pathogenic germline mutations in high-risk ovarian cancer susceptibility genes (including BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2). Data Availability: Willing to provide informed consent and allow access to clinical records, genetic testing reports, and follow-up data (bidirectional cohort). Psychosocial Status: Ability to complete quality of life and psychological assessment scales (e.g., GCS, SF-36, FSFI). Exclusion Criteria: * Prior Malignancy: History of ovarian, fallopian tube, or primary peritoneal cancer prior to the baseline intervention. Synchronous Malignancy: Diagnosis of any other advanced-stage malignancy. Inability to Follow-up: Significant psychological, social, or geographical factors that would prevent regular long-term follow-up (3 years). Previous Extensive Pelvic Surgery: History of extensive pelvic surgery that precludes the feasibility of laparoscopic prophylactic salpingectomy or oophorectomy.
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Associate Chief Physician/Associate Consultant, Doctor
- Email: yuanli@bjmu.edu.cn
- Phone: 18610689868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.