• 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.
Woman between 35 to 50 years
Addressed to or followed in an oncogenetic counselling
Identified risk of tubo-ovarian or primary peritoneal carcinoma based on mutational status (BRCA1, BRCA 2, RAD51C, RAD51D, PALB2). The list of considered mutations may be extended during the study.
Written informed consent
Prior bilateral oophorectomy and/or bilateral salpingectomy for any reason (prophylactic surgery or other)
Personal history of ovarian, fallopian tube or primary peritoneal cancer
Menopause defined by
In women with prior chemotherapy: the absence of menses for at least 24 months