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

NANot yet recruitingINTERVENTIONAL
Enrollment

1,100

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

March 31, 2065

Study Completion Date

March 31, 2065

Conditions
Tubo-ovarian CarcinomaHigh-grade Serous CarcinomaPrimary Peritoneal Carcinoma Stage IIIPrimary Peritoneal Carcinoma Stage IVPrimary Peritoneal Carcinoma
Interventions
PROCEDURE

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"

PROCEDURE

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.

Trial Locations (23)

Unknown

Institut Bergonié, Bordeaux

Centre François Baclesse, Caen

Centre Jean Perrin, Clermont-Ferrand

Centre Hospitalier Universitaire Dijon Bourgogne, Dijon

Centre hospitalier universitaire Grenoble-Alpes, Grenoble

Centre Hospitalier Universitaire de Lille, Lille

Centre Oscar Lambret, Lille

Clinique du Bois, Lille

Centre Léon Bérard, Lyon

Institut Paoli-Calmettes, Marseille

Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU, Nantes

Centre Antoine Lacassagne, Nice

Gustave Roussy, Paris

Hôpital de la Pitié Salpêtrière - AP-HP, Paris

Hôpital Institut CURIE, Paris

Hôpital Tenon AP-HP, Paris

Institut Godinot, Reims

Centre Henri Becquerel, Rouen

Hôpitaux Privés Rouennais, Rouen

Hôpital de Saint-Cloud, Saint-Cloud

Institut universitaire du cancer de Toulouse, Toulouse

Hôpital Simone Veil - CH de Troyes, Troyes

Centre Hospitalier de Valenciennes, Valenciennes

All Listed Sponsors
lead

Centre Oscar Lambret

OTHER

NCT06726330 - Risk-reducing Strategies, Including Fimbriectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer | Biotech Hunter | Biotech Hunter