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Risk-reducing Strategies, Including Fimbriectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer
Sponsor: Centre Oscar Lambret
Summary
• 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.
Official title: Evaluation of Risk Control of Advanced Stage Tubo-ovarian or Primary Peritoneal Carcinoma Associated With Ovarian Carcinoma Risk-reducing Strategies, Including Fimbriectomy With Delayed Oophorectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer
Key Details
Gender
FEMALE
Age Range
35 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
1100
Start Date
2027-03
Completion Date
2071-03
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Fimbriectomy Followed by Delayed Oophorectomy (F-DO)
This 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
This 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.
Locations (23)
Centre Léon Bérard
Lyon, France, France
Institut universitaire du cancer de Toulouse
Toulouse, France, France
Centre Hospitalier de Valenciennes
Valenciennes, France, France
Institut Bergonié
Bordeaux, France
Centre François Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Hospitalier Universitaire Dijon Bourgogne
Dijon, France
Centre hospitalier universitaire Grenoble-Alpes
Grenoble, France
Centre Hospitalier Universitaire de Lille
Lille, France
Centre Oscar Lambret
Lille, France
Clinique du Bois
Lille, France
Institut Paoli-Calmettes
Marseille, France
Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU
Nantes, France
Centre Antoine Lacassagne
Nice, France
Gustave Roussy
Paris, France
Hôpital de la Pitié Salpêtrière - AP-HP
Paris, France
Hôpital Institut CURIE
Paris, France
Hôpital Tenon AP-HP
Paris, France
Institut Godinot
Reims, France
Centre Henri Becquerel
Rouen, France
Hôpitaux Privés Rouennais
Rouen, France
Hôpital de Saint-Cloud
Saint-Cloud, France
Hôpital Simone Veil - CH de Troyes
Troyes, France