NCT06726330Not yet recruiting
Risk-reducing Strategies, Including Fimbriectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer
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
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
• 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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1100 (estimated)
- First submitted
- 25 Nov 2024
- Start date
- Mar 2027
- Primary completion date
- Mar 2071
- Lead sponsor
- Centre Oscar Lambret
- Diseases
- Ovarian cancer
- NCT number
- NCT06726330
What you commit to
- Study type: Interventional
- Planned participants: 1100
- From Mar 2027 to the primary completion date, Mar 2071
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior bilateral oophorectomy and/or bilateral salpingectomy for any reason (prophylactic surgery or other)
- Menopause defined by
- In women without prior chemotherapy If no prior hysterectomy: the absence of menses for at least 12 months, or FSH \> 20 UI/L with low estrogen level with no identified gynecological or endocrine explanation. Amenorrhea related to an intrauterine device, vaginal ring or estrogen-progestin pill will not be considered as menopause.
- If prior hysterectomy: FSH \>20 UI/L with low estrogen level (with or without vasomotor symptoms, genitourinary symptoms)
- In women with prior chemotherapy: the absence of menses for at least 24 months
- In all women with progesterone-loaded intra-uterine device (IUD): FSH \> 20 UI/L with low estrogen level
Other illness
- Personal history of ovarian, fallopian tube or primary peritoneal cancer
Other
- Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)
- Patient under guardianship or curatorship
Who the study is looking for
- 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
- Patient covered by the French "Social Security"
Age in the registry: 35 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Centre Hospitalier Universitaire Dijon Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Centre hospitalier universitaire Grenoble-Alpes Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Clinique du Bois Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Hôpital Tenon AP-HP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Gustave Roussy Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Institut CURIE Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital de la Pitié Salpêtrière - AP-HP Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Institut Godinot Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Hôpitaux Privés Rouennais Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Hôpital de Saint-Cloud Coordinator of this site? Confirm its status | Saint-Cloud | France | Unknown status |
| Institut universitaire du cancer de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Hôpital Simone Veil - CH de Troyes Coordinator of this site? Confirm its status | Troyes | France | Unknown status |
| Centre Hospitalier de Valenciennes Coordinator of this site? Confirm its status | Valenciennes | France | Unknown status |
Related publications
- FIMBRIMENOP-2402 trial: evaluating fimbriectomy with delayed oophorectomy in patients with high-risk tubo-ovarian cancer.Int J Gynecol Cancer · 2026 · PMID 42140840
This page is information, not medical advice. Discuss any trial with your doctor.