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.
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).
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.
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.
Cohort
Cross-sectional
Not listed
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.
Incidence of Breast Cancer
Occurrence of new-onset breast cancer during the follow-up period, particularly for BRCA1/2 mutation carriers.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
