Study of Preventive Surgery Options for Women with High Genetic Risk of Hereditary Ovarian Cancer Observing Effects on Cancer Risk, Ovarian Function, and Quality of Life

What this Trial Is About

Researchers are studying women who have a moderate-to-high genetic risk for hereditary ovarian cancer to understand how different preventive surgical options work and how safe they are. They aim to compare individualized preventive surgeries, like removing fallopian tubes now and delaying ovary removal, against standard care or close monitoring to see which best reduces ovarian cancer risk. The study also looks at how these surgeries affect ovarian function and quality of life. The study follows women who carry specific gene mutations such as BRCA1, BRCA2, RAD51C, and others. Participants choose one of three paths with their doctors standard risk-reducing surgery removing both fallopian tubes and ovaries at once RRSO, removing fallopian tubes first and delaying ovary removal RS-DO, or close monitoring with ultrasound and blood tests if they decline surgery. The study includes both past data from 2020 onward and new participants, with follow-up planned for at least 3 years. Participants will have their clinical data collected, including surgical pathology reviewed centrally to detect early signs of cancer. They will complete quality of life and psychological assessments over time. Researchers will track ovarian, fallopian tube, and peritoneal cancer incidence as the main outcome over up to 15 years. Safety, quality of life, menopausal symptoms, and psychological distress are also monitored. The study uses strict data validation and regular audits to ensure accuracy.

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