Radical Fimbriectomy for Young BRCA Mutation Carriers

Not Applicable

Active, not recruiting

• Conditions: BRCA2 Mutation; Hereditary Breast and Ovarian Cancer; BRCA1 Mutation
• Interventions: Procedure: Radical fimbriectomy; Other: Histopathology SEE-FIM

• Registration Number: NCT01608074
• Lead Sponsor: Centre Oscar Lambret

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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2033-08
• Study Completion: 2033-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 123

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BRCA mutation carriers	Radical fimbriectomy	Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer. Radical fimbriectomy. Histopathology SEE-FIM
BRCA mutation carriers	Histopathology SEE-FIM	Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer. Radical fimbriectomy. Histopathology SEE-FIM

Primary Outcome Measures

Name	Time	Method
Rate of pelvic cancer	an expected average of 15 years	Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause

Secondary Outcome Measures

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

Trial Locations

Locations (14)

Centre Jean Perrin; 🇫🇷 Clermont-ferrand, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

IUCT-O Toulouse; 🇫🇷 Toulouse, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Polyclinique du Parc Rambot; 🇫🇷 Aix en Provence, France

CHR-U; 🇫🇷 Lille, France

Hôpital Privé VA; 🇫🇷 Villeneuve-d'Ascq, France

Clinique du Bois - Bourgogne Center; 🇫🇷 Lille, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Institut Curie; 🇫🇷 Paris, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France