An observational study in Ovarian Cancer and Breast Cancer, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Peking University Third Hospital · Observational
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.
Study Rationale and Background Epithelial ovarian cancer (OC) remains a significant health burden in China, with high mortality due to the lack of effective early screening methods. Approximately 20% of OC cases are attributed to hereditary factors, primarily germline pathogenic variants in BRCA1/2 and other homologous recombination repair (HRR) genes.
The traditional standard for risk reduction is Risk-Reducing Salpingo-Oophorectomy (RRSO). However, the "dualistic model" of ovarian carcinogenesis suggests that a significant proportion of high-grade serous carcinomas (HGSC) originate as Serous Tubal Intraepithelial Carcinoma (STIC) in the fallopian tubes. This provides a biological rationale for Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO, also known as RS-DO). This study aims to establish a Chinese bidirectional cohort to evaluate the effectiveness, safety, and impact on quality of life (QoL) of individualized prophylactic surgical strategies.
Study Design and Cohort Construction This is a bidirectional (combined retrospective and prospective) cohort study.
Retrospective Component: Data will be extracted from clinical records dating back to 2020 for individuals who meet the high-risk genetic criteria and have previously undergone risk-reducing surgery or entered clinical monitoring.
Prospective Component: Eligible participants will be recruited and followed for a minimum of 5 years. Participants are categorized into three cohorts based on the clinical intervention received:
RRSO Group: Concomitant removal of fallopian tubes and ovaries.
RS-DO Group: Initial salpingectomy followed or not followed by delayed oophorectomy (typically at age 45-50 or based on mutation type).
Close Monitoring Group: For those declining surgery, intensive surveillance via transvaginal ultrasound and serum CA-125/HE4 testing.
Quality Assurance and Registry Procedures
To ensure the highest data integrity, the following procedures are implemented:
Centralized Pathology Review: All surgical specimens from prophylactic procedures must undergo the SEE-FIM (Sectioning and Extensively Examining the FIMbria) protocol to detect occult STIC or early invasive carcinoma.
Data Validation: An Electronic Data Capture (EDC) system is utilized with automated data checks for range, consistency, and logical errors.
Source Data Verification (SDV): Regular on-site or remote audits will be conducted on 20% of the registry entries to verify accuracy against primary medical records and genetic testing reports.
Data Dictionary: All variables are predefined in a comprehensive data dictionary. Genetic variants are classified according to the American College of Medical Genetics and Genomics (ACMG) guidelines. Clinical complications are graded using the Clavien-Dindo classification.
Statistical Analysis Plan (SAP)
Sample Size: Based on the estimated incidence of OC in the Chinese high-risk population, the study aims to enroll approximately 480 participants (160 per arm) to provide sufficient power (80%) for survival analysis.
Primary Endpoint Analysis: The cumulative incidence of ovarian, fallopian tube, and peritoneal cancer will be estimated using the Kaplan-Meier method. Differences between intervention groups will be compared using the Log-rank test and Cox Proportional Hazards Models, adjusting for age, parity, and specific mutation types (e.g., BRCA1 vs. BRCA2 vs. RAD51C/D).
Secondary Endpoint Analysis: Changes in menopausal symptoms and sexual function scores (GCS, SF-36, FSFI) will be analyzed using Repeated Measures ANOVA (RM-ANOVA) or ANCOVA to adjust for baseline differences and hormone replacement therapy (HRT) use.
Missing Data: A multiple imputation approach will be used for missing covariates, while sensitivity analysis will be performed to assess the impact of loss to follow-up.
The registry operates under standardized protocols for:
Standardized pre-test and post-test genetic counseling.
Uniform surgical techniques for salpingectomy and oophorectomy.
Standardized follow-up intervals (every 6-12 months).
Adverse event reporting and management of unexpected pathological findings (STIC).
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 480 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
Time frame: From the date of enrollment/surgery up to 15 years.
Incidence of Breast Cancer
Occurrence of new-onset breast cancer during the follow-up period, particularly for BRCA1/2 mutation carriers.
Time frame: From the date of enrollment up to 15 years.
Incidence of Serous Tubal Intraepithelial Carcinoma (STIC)
Frequency of STIC or occult invasive carcinoma detected in the surgical specimens of the fallopian tubes, examined using the standardized SEE-FIM pathological protocol.
Time frame: At the time of prophylactic surgery (approx. 1 day)
Comprehensive Assessment of Quality of Life and Menopausal Symptoms
A multi-dimensional evaluation of the participants' physical and endocrine-related health status using Greene Climacteric Scale (GCS), SF-36 Health Survey and other scales.
Time frame: Baseline, 1 month, 6 months and 1 year post-enrollment.
Evaluation of Psychological Distress
An assessment of the psychosocial impact of prophylactic surgery and cancer-related anxiety using Cancer Worry Scale (CWS), Female Sexual Distress Scale (FSDS) and other scales.
Time frame: Baseline, 1 month, 6 months and 1 year post-enrollment.
Plan to share: Undecided
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