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

NCT07532434 | Recruiting DMC

• 1 other identifier: M20250883
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ovarian Cancer; Breast Cancer

Keywords

Hereditary Ovarian Cancer (HOC); BRCA1/2 Mutation Carriers; Risk-Reducing Salpingo-Oophorectomy (RRSO); Bidirectional Cohort Study; Risk-Reducing Salpingo-Oophorectomy（RRSO）

Outcome Measures

Primary Outcomes (1)

• Incidence of Ovarian Cancer

  The primary efficacy endpoint is the development of histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer among high-risk mutation carriers in different intervention groups.

  From the date of enrollment/surgery up to 15 years.

Secondary Outcomes (4)

• Incidence of Breast Cancer

  From the date of enrollment up to 15 years.

• Incidence of Serous Tubal Intraepithelial Carcinoma (STIC)

  At the time of prophylactic surgery (approx. 1 day)

• Comprehensive Assessment of Quality of Life and Menopausal Symptoms

  Baseline, 1 month, 6 months and 1 year post-enrollment.

• Evaluation of Psychological Distress

  Baseline, 1 month, 6 months and 1 year post-enrollment.

Study Arms (1)

Label 1: Standard RRSO Group. Label 2: Individualized RS-DO Group. Label 3: Close Monitoring Group

Description of Label 1: Participants undergoing concurrent bilateral salpingo-oophorectomy per guidelines. Description of Label 2: Participants undergoing salpingectomy with delayed oophorectomy to preserve hormones.Description of Label 3: Participants declining surgery and choosing regular ultrasound and CA-125 surveillance.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study specifically focuses on the prevention of hereditary ovarian, fallopian tube, and peritoneal cancers. Participation is limited to individuals assigned female at birth, as the primary surgical interventions (Risk-Reducing Salpingo-Oophorectomy and Salpingectomy) and the physiological assessment of ovarian function are exclusively applicable to the female reproductive system.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study targets Chinese women at moderate-to-high genetic risk for hereditary ovarian cancer (HOC). The population includes documented carriers of pathogenic or likely pathogenic (P/LP) germline mutations in high-risk susceptibility genes, primarily BRCA1 and BRCA2, as well as other HRR-related genes such as RAD51C, RAD51D, BRIP1, and PALB2. The population encompasses both premenopausal and postmenopausal women seeking individualized risk-management strategies.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (12)

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• Steenbeek MP,van Bommel MHD,intHout J,Peterson CB,Simons M,Roes KCB,Kets M,Norquist BM,Swisher EM,Hermens RPMG,TUBA-WISP II consortium,Lu KH,de Hullu JA

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  BACKGROUND

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  BACKGROUND

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  PMID: 33538338 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Surgical Tissue Specimens: Formalin-fixed paraffin-embedded (FFPE) blocks and slides of the fallopian tubes and ovaries obtained during risk-reducing surgery (RRSO or RS-DO). These specimens undergo standardized pathological examination using the SEE-FIM protocol to detect Serous Tubal Intraepithelial Carcinoma (STIC) and occult invasive carcinoma. Genetic Material: Peripheral blood samples or saliva samples collected for germline genetic testing to identify pathogenic or likely pathogenic variants in HOC-related genes (e.g., BRCA1, BRCA2, RAD51C/D, BRIP1, PALB2). Optional Biobanking: Serum and plasma samples collected during follow-up for future biomarker research related to ovarian cancer early detection.

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Associate Chief Physician/Associate Consultant, Doctor

CONTACT

18610689868; yuanli@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2035
• Last Updated: April 15, 2026

Record last verified: 2026-02

Locations

CN (1)