Actively Recruiting

Age: 18Years +
FEMALE
NCT07532434

A Bidirectional Cohort Study on Prophylactic Resection Surgery in Populations at Moderate-to-High Risk for Hereditary Ovarian Cancer

Led by Peking University Third Hospital · Updated on 2026-04-15

480

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this multi-center observational study is to learn about the effectiveness and safety of different prophylactic (preventive) surgical options in women at moderate-to-high genetic risk for hereditary ovarian cancer (HOC). The main questions it aims to answer are: Does individualized prophylactic surgery (such as removing fallopian tubes now and delaying ovary removal) effectively reduce the risk of developing ovarian cancer compared to standard care or close monitoring? How do these different surgical interventions affect a woman's ovarian function and quality of life? What Participants Will Do: Participants who are healthy carriers of specific genetic mutations (such as BRCA1/2, RAD51C/D, etc.) will be followed in a bidirectional cohort. Depending on the medical care and surgical path they choose with their doctors (Standard RRSO, Delayed Oophorectomy, or Close Monitoring), researchers will collect their clinical data, surgical pathology results, and follow-up information regarding cancer incidence and quality of life for 3 years.

CONDITIONS

Official Title

A Bidirectional Cohort Study on Prophylactic Resection Surgery in Populations at Moderate-to-High Risk for Hereditary Ovarian Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female gender, 18 years or older at enrollment
  • Carriers of pathogenic or likely pathogenic mutations in high-risk ovarian cancer genes (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2)
  • Willing to provide informed consent and allow access to medical and genetic records
  • Ability to complete quality of life and psychological assessments (e.g., GCS, SF-36, FSFI)
Not Eligible

You will not qualify if you...

  • History of ovarian, fallopian tube, or primary peritoneal cancer before baseline intervention
  • Diagnosis of any other advanced-stage cancer
  • Significant psychological, social, or geographic barriers preventing regular 3-year follow-up
  • Prior extensive pelvic surgery that prevents laparoscopic prophylactic salpingectomy or oophorectomy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, Beijing Municipality, China, 100191

Actively Recruiting

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Research Team

A

Associate Chief Physician/Associate Consultant, Doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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