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

Study acronym: FIMBRIMENOP
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Mar 2065 to Mar 2071
    • Start date: Mar 2025 to Mar 2027
    • Site details revised at 3 of 23 sites
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
• 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.
Trial Details
NCT Number NCT06726330
Lead Sponsor Centre Oscar Lambret
Conditions
(from sponsor)
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov