Radical Fimbriectomy for Young BRCA Mutation Carriers (FIMBRIECTOMIE)

Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma

Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.

Study Overview

• Status: Active, not recruiting
• Conditions: BRCA1 Mutation; BRCA2 Mutation; Hereditary Breast and Ovarian Cancer
• Intervention / Treatment: Procedure: Radical fimbriectomy; Other: Histopathology SEE-FIM

Detailed Description

Most of ovarian carcinomas related to BRCA 1 or 2 mutations are of fallopian tube origin and especially from its distant part called the fimbria. These tubal, ovarian or primary peritoneal carcinomas are quite always of high grade serous type. They cannot be effectively screened due to the quickness of their evolution. In this context, a laparoscopic bilateral salpingo-oophorectomy (BSO) is the recommended prophylactic procedure.

Some BRCA-mutated women are reluctant to undergo this procedure considering the numerous adverse effects on body and quality of life, especially when hormonal replacement is forbidden. This refusal makes them at risk of developing a serous pelvic carcinoma.

The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France
    • Polyclinique du Parc Rambot
  • Bordeaux, France
    • Institut Bergonie
  • Clermont-Ferrand, France
    • Centre Jean Perrin
  • Lille, France
    • Centre Oscar Lambret
  • Lille, France
    • CHR-U
  • Lille, France
    • Clinique du Bois - Bourgogne Center
  • Lyon, France
    • Hospices Civils de Lyon
  • Marseille, France
    • Institut Paoli Calmettes
  • Nice, France
    • Centre Antoine Lacassagne
  • Paris, France
    • Institut Curie
  • Rouen, France
    • Centre Henri Becquerel
  • Toulouse, France
    • IUCT-O Toulouse
  • Villejuif, France
    • Institut Gustave Roussy
  • Villeneuve-d'Ascq, France
    • Hôpital Privé VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Woman aged over 35 years
• When project of childbearing is fulfilled
• With a BRCA 1 or 2 mutation, or a family history of breast/ovarian cancer
• Unprepared to undergo bilateral annexectomy
• With or without breast cancer
• Patient affiliated to health insurance
• Dated and signed informed consent

Exclusion Criteria:

• Menopausal woman defined as :

Bilateral oophorectomy without hysterectomy and amenorrhea more than 12 months and/or FSH> 20 UI/l History of hysterectomy and FSH> 20 UI/l

• Pregnant or breastfeeding woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BRCA mutation carriers; Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer. Radical fimbriectomy. Histopathology SEE-FIM

Procedure: Radical fimbriectomy; Laparoscopic bilateral radical fimbriectomy : Complete resection of the tubes, from the uterine tube (up against the uterus) to the fimbriae, with resection of the part of the ovary adjacent to the ovarian fimbriae (adhering to the ovary); Other: Histopathology SEE-FIM; Anatomopathological study of surgical specimens; Other Names: Sectioning and Extensively Examining the FIMbria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of pelvic cancer	Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause	an expected average of 15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity associated with the radical prophylactic fimbriectomy	Morbidity will be assessed according to the Clavien-Dindo classification up to 30 days after the procedure and according to the NCI-CTCAE v4.0 grading scale beyond that time	Up to 30 days after the surgery
Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens	Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens	Within 1 month after fimbriectomy, and within 1 month after oophorectomy
Incidence of breast cancer on patients without breast cancer before fimbriectomy, and incidence (de novo or recurrence) of breast cancer on the overall study population	Number of cases of breast cancer or breast cancer recurrence observed	an expected average of 15 years
Rate of secondary oophorectomies and associated morbidity, and reasons for oophorectomy if decided before the age of 50 et before menopausis	Number of oophorectomies and time between fimbriectomy and oophorectomy Complications according to NCI-CTCAE v4.0 grading scale	an expected average of 15 years
Proteomic profile of tissues from radical fimbriectomy	Immunostaining is realised on sections of ovary portion, fimbriae and fallopian tubes, then tumoral zones are selected for spatially resolved gun microproteomic analysis	Up to 7 years after sample collection
Proportion of menopausal women before oophorectomy or at the LPLV without oophorectomy, and rate patients who experienced early menopause (before the age of 40)	Number of cases of menopausis an early menopausis observed	an expected average of 15 years
Proportion of benign histological abnormalities on radical Fimbriectomy specimens	Number of benign histological abnormalities on the operative specimens	Within 1 month after fimbriectomy
Patient's satisfaction at distance from Radical Fimbriectomy	Patient satisfaction survey	Up to 10 years

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: CTD-CNO; Laboratoire PRISM
• Investigators: Principal Investigator: Carlos MARTINEZ-GOMEZ, MD, Centre Oscar Lambret

Publications and helpful links

General Publications

• Wisztorski M, Aboulouard S, Roussel L, Duhamel M, Saudemont P, Cardon T, Narducci F, Robin YM, Lemaire AS, Bertin D, Hajjaji N, Kobeissy F, Leblanc E, Fournier I, Salzet M. Fallopian tube lesions as potential precursors of early ovarian cancer: a comprehensive proteomic analysis. Cell Death Dis. 2023 Sep 30;14(9):644. doi: 10.1038/s41419-023-06165-5.
• Leblanc E, Narducci F, Ferron G, Mailliez A, Charvolin JY, Houssein EH, Guyon F, Fourchotte V, Lambaudie E, Crouzet A, Fouche Y, Gouy S, Collinet P, Caquant F, Pomel C, Golfier F, Vaini-Cowen V, Fournier I, Salzet M, Tresch E, Probst A, Lemaire AS, Deley ML, Hudry D. Prophylactic Radical Fimbriectomy with Delayed Oophorectomy in Women with a High Risk of Developing an Ovarian Carcinoma: Results of a Prospective National Pilot Study. Cancers (Basel). 2023 Feb 10;15(4):1141. doi: 10.3390/cancers15041141.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2012
• Primary Completion (Estimated): August 1, 2033
• Study Completion (Estimated): August 1, 2033

Study Registration Dates

• First Submitted: May 15, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (Estimated): May 30, 2012

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: BRCA2; BRCA1; Salpingectomy; Prophylactic surgery; Fimbriectomy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Neoplastic Syndromes, Hereditary; Breast Neoplasms; Ovarian Neoplasms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Hereditary Breast and Ovarian Cancer Syndrome
• Other Study ID Numbers: FIMBRIECTOMIE-1106; PHRC-K11-106 (Other Grant/Funding Number: DGOS/INCA); 2011-A01213-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No