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Studies

Interventional Not yet recruiting

NCT06726330 on ClinicalTrials.gov

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

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

  • Sponsor: Centre Oscar Lambret
  • Enrollment: 1100 (Estimated)
  • Study start: 2027-03-01 (Estimated)
  • Primary completion: 2071-03-01 (Estimated)
  • Study completion: 2071-03-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: This is a non-randomized controlled preference trial. Participants decide their surgical approach based on counseling. The study accommodates real-world clinical practices, empowering patients in the decision-making process.
  • Masking: None
  • PrimaryPurpose: Prevention

Brief 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.

Conditions

  • Tubo-ovarian Carcinoma
  • High-grade Serous Carcinoma
  • Primary Peritoneal Carcinoma Stage III
  • Primary Peritoneal Carcinoma Stage IV
  • Primary Peritoneal Carcinoma

Intervention / Treatment

  • Procedure: Fimbriectomy Followed by Delayed Oophorectomy (F-DO)
  • Procedure: Bilateral Salpingo-Oophorectomy

Primary Outcome Measures

  • Incidence of Advanced-Stage (Stage III or IV) Tubo-Ovarian or Primary Peritoneal Carcinoma (Up to 70 years of age)
    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.

Countries

France

Locations and Investigators

  • Centre Léon Bérard, Lyon, France
    • Léa ROSSI, MD (Principal Investigator)
    • Pauline ROCHEFORT, MD
    • Nicolas CHOPIN, MD
  • Institut universitaire du cancer de Toulouse, Toulouse, France
  • Centre Hospitalier de Valenciennes, Valenciennes, France
    • Yves BORGHESI, MD (Principal Investigator)
    • Alfane BRAHIMI, MD
  • Institut Bergonié, Bordeaux, France
  • Centre François Baclesse, Caen, France
  • Centre Jean Perrin, Clermont-Ferrand, France
    • Caroline CORNOU, MD (Principal Investigator)
    • Mathilde GAY BELLILE, MD
  • Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, France
  • Centre hospitalier universitaire Grenoble-Alpes, Grenoble, France
    • Anne Cécile PHILIPPE, MD (Principal Investigator)
    • LEGRAND, MD
  • Centre Hospitalier Universitaire de Lille, Lille, France
  • Centre Oscar Lambret, Lille, France
    • Pauline SMIS
    • Carlos MARTINEZ GOMEZ, MD (Principal Investigator)
    • AUDREY MAILLIEZ, MD
  • Clinique du Bois, Lille, France
    • Jean Yves CHARVOLIN, MD (Principal Investigator)
    • Claude ADENIS, MD
  • Institut Paoli-Calmettes, Marseille, France
    • Camille JAUFFRET, MD (Principal Investigator)
    • Catherine NOGUES, MD
  • Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU, Nantes, France
    • Célia CHALUMEAU, MD (Principal Investigator)
    • ABADIE Caroline, MD
    • Capucine DELNATTE, MD
  • Centre Antoine Lacassagne, Nice, France
    • Véronique MARI, MD (Principal Investigator)
    • Marie GOSSET, MD
  • Gustave Roussy, Paris, France
  • Hôpital de la Pitié Salpêtrière - AP-HP, Paris, France
  • Hôpital Institut CURIE, Paris, France
    • Virginie FOURCHOTTE, MD (Principal Investigator)
    • Chrystelle COLAS, MD
  • Hôpital Tenon AP-HP, Paris, France
  • Institut Godinot, Reims, France
    • Judicael HOTTON, MD (Principal Investigator)
    • Fanny BRAYOTEL, MD
  • Centre Henri Becquerel, Rouen, France
    • Agathe CROUZET, MD (Principal Investigator)
    • Jean Christophe TERY, MD
  • Hôpitaux Privés Rouennais, Rouen, France
    • Benoit RESCH, MD (Principal Investigator)
    • Jean Christophe TERY, MD (Principal Investigator)
  • Hôpital de Saint-Cloud, Saint-Cloud, France
  • Hôpital Simone Veil - CH de Troyes, Troyes, France

Study Officials