Risk-reducing Strategies, Including Fimbriectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer

• FIMBRIMENOP-2402 study aims to evaluate the long-term management of cancer risks in premenopausal women who have a genetic predisposition to tubo-ovarian or primary peritoneal carcinoma, such as mutations in BRCA1, BRCA2, RAD51C, RAD51D, or PALB2 genes. This study offers an alternative to standard preventive surgery (bilateral salpingo-oophorectomy or BSO) by exploring the use of fimbriectomy (removal of the fallopian tube's fimbria) followed by delayed oophorectomy (removal of ovaries at menopause). It's a pragmatic multicenter trial conducted across various medical centers, employing a non-randomized controlled preference design to compare two preventive surgical strategies: 1. Fimbriectomy followed by delayed oophorectomy (F-DO). 2. Bilateral salpingo-oophorectomy (BSO). The primary objective is to compare the long-term efficacy of two preventive surgical strategies : 1. Fimbriectomy followed by delayed oophorectomy (F-DO). 2. Bilateral salpingo-oophorectomy (BSO). As for the design of the study, participants choose their preferred surgical strategy during or after oncogenetic counseling, ensuring patient autonomy in decision-making. • Follow-Up: Long-term follow-up includes clinical assessments, data collection from medical networks, and integration with national health databases to track outcomes up to the age of 70. This is the first French comparative study in real-world settings and is classified as interventional research (RIPH1) under French regulations, given the need to validate fimbriectomy efficacy.

NCT Number	NCT06726330
Lead Sponsor	Centre Oscar Lambret
Conditions	Tubo-ovarian Carcinoma, High-grade Serous Carcinoma, Primary Peritoneal Carcinoma Stage III, Primary Peritoneal Carcinoma Stage IV, Primary Peritoneal Carcinoma
Enrollment	1,100 participants
Start Date	2027-03
Primary Completion	2071-03 (estimated)
Study Completion	2071-03 (estimated)
Updated on ClinicalTrials.gov	2026-03-17