Radical Fimbriectomy for Young BRCA Mutation Carriers

NCT ID: NCT01608074

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2033-08-31

Brief Summary

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.

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

Conditions

BRCA1 Mutation; BRCA2 Mutation; Hereditary Breast and Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BRCA mutation carriers

Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer.

Radical fimbriectomy. Histopathology SEE-FIM

Group Type: EXPERIMENTAL

Radical fimbriectomy

Intervention Type: PROCEDURE

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)

Histopathology SEE-FIM

Intervention Type: OTHER

Anatomopathological study of surgical specimens

Interventions

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)

Intervention Type: PROCEDURE

Histopathology SEE-FIM

Anatomopathological study of surgical specimens

Intervention Type: OTHER

Other Intervention Names

Sectioning and Extensively Examining the FIMbria

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CTD-CNO

UNKNOWN

Sponsor Role: collaborator

Laboratoire PRISM

UNKNOWN

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos MARTINEZ-GOMEZ, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

Polyclinique du Parc Rambot

Aix-en-Provence, , France

Institut Bergonié

Bordeaux, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre Oscar Lambret

Lille, , France

CHR-U

Lille, , France

Clinique du Bois - Bourgogne Center

Lille, , France

Hospices Civils de Lyon

Lyon, , France

Institut Paoli Calmettes

Marseille, , France

Centre Antoine Lacassagne

Nice, , France

Institut Curie

Paris, , France

Centre Henri Becquerel

Rouen, , France

IUCT-O Toulouse

Toulouse, , France

Institut Gustave Roussy

Villejuif, , France

Hôpital Privé VA

Villeneuve-d'Ascq, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 37775701 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36831483 (View on PubMed)

Other Identifiers

FIMBRIECTOMIE

Identifier Type: -

Identifier Source: org_study_id