• 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
Parallel
Fimbriectomy Followed by Delayed Oophorectomy (F-DO)
Procedure/SurgeryThis intervention involves two stages: 1. Fimbriectomy: A preventive surgical procedure that removes the fimbrial end of the fallopian tubes, including adjacent ovarian tissue, while preserving ovarian function to avoid premature menopause. 2. Delayed Oophorectomy: The removal of ovaries, performed at menopause or later, depending on patient preference and clinical guidelines. * The F-DO strategy aims to reduce the risk of tubo-ovarian or primary peritoneal carcinoma, which often originates in the fallopian tubes, while minimizing the adverse effects of premature menopause such as cardiovascular disease and osteoporosis
Bilateral Salpingo-Oophorectomy
Procedure/SurgeryThis standard surgical intervention involves the removal of both fallopian tubes and ovaries (BSO) to eliminate the risk of tubo-ovarian or primary peritoneal carcinoma. It is typically recommended for women with a genetic predisposition (e.g., BRCA1/2 mutations) around the age of 40-45. While highly effective in preventing cancer, BSO induces premature menopause, which may result in long-term side effects such as increased cardiovascular risk, osteoporosis, and cognitive decline.
Incidence of Advanced-Stage (Stage III or IV) Tubo-Ovarian or Primary Peritoneal Carcinoma
The study evaluates the long-term incidence of advanced-stage (Stage III or IV) tubo-ovarian or primary peritoneal carcinoma. This measure will be assessed using annual clinical evaluations, patient questionnaires, medical records, and data extracted from the French National Health Database (SNDS) and regional oncogenetic networks. Time from study entry to cancer diagnosis will be calculated, with death without cancer considered as a competing event. Data will be censored at the last follow-up visit for participants alive without cancer.
Incidence of Any-Stage Tubo-Ovarian or Primary Peritoneal Carcinoma
Time from study entry to diagnosis of any stage of tubo-ovarian or primary peritoneal carcinoma, including pre-invasive lesions such as serous tubal intraepithelial carcinoma (STIC).
Age at Menopause
The age at menopause will be determined through clinical assessments, hormone level measurements, and patient-reported outcomes. Criteria include cessation of menses for at least 12 months in non-hysterectomized women or FSH levels \>20 UI/L with low estrogen levels.
Incidence of Cardiovascular Events and Osteoporosis-Related Events
Long-term cardiovascular (e.g., myocardial infarction, stroke) and osteoporosis-related events (e.g., hip fractures) will be recorded from clinical evaluations and the SNDS database.
Overall Survival
Overall survival will be tracked using clinical data, SNDS records, and vital status updates.
Benefit-Risk Ratio Analysis
Composite analysis of event-free survival, including advanced-stage tubo-ovarian or primary peritoneal carcinoma, breast cancer, cardiovascular events, osteoporosis-related events, and death from any cause. This measure integrates the oncological and quality-of-life impacts of the surgical strategies.
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