Preventive removal or staged removal of fallopian tubes and ovaries for women with hereditary ovarian cancer risk
Official title: A Bidirectional Cohort Study on Prophylactic Resection Surgery in Populations at Moderate-to-High Risk for Hereditary Ovarian Cancer
Run by Peking University Third Hospital · NCT07532434 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 480 (estimated) |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | September 30, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2035 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT07532434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
EHR-based approach to boost HBOC genetic testing in at-risk women
A new EHR tool-based program tests whether computer prompts and real patient resources can help more women with family histories of breast or ovarian cancer get HBOC genetic testing.
-
68Ga-SorB PET/CT imaging for solid tumors
This study tests a new PET tracer called 68Ga-SorB to see if it can safely and accurately detect tumors in adults with melanoma, liver, lung, breast, pancreatic, ovarian cancer, or cholangiocarcinoma.
-
Romiplostim N01 plus ATRA for persistent chemotherapy-induced low platelets after remission from gynecologic, breast, or lung cancer
This trial tests whether adding ATRA to Romiplostim N01 helps people keep a safe platelet count after finishing chemotherapy for certain cancers.
-
CAIX-targeted 18F-T2 PET/CT imaging in solid tumors
This study tests a CAIX-specific radioactive tracer to see if PET/CT can help visualize solid tumors and checks safety and radiation exposure in adults with certain cancers.
-
RGT-490 for adults with PIK3CA-mutated advanced solid tumors
This trial will test RGT-490, an oral medicine, in adults whose advanced solid tumors carry a PIK3CA mutation and have progressed after prior therapy.
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.