Radical Fimbriectomy for Young BRCA Mutation Carriers

Centre Oscar Lambret

Status: Active, not recruiting

Conditions: BRCA2 Mutation; Hereditary Breast and Ovarian Cancer; BRCA1 Mutation

Treatments: Procedure: Radical fimbriectomy; Other: Histopathology SEE-FIM

Study type: Interventional

Funder types: Other

Identifiers

NCT01608074

FIMBRIECTOMIE-1106

Details and patient eligibility

About

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.

Full 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

Enrollment: 123 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

BRCA mutation carriers

Experimental group

Description:

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

Treatment:

Other: Histopathology SEE-FIM

Procedure: Radical fimbriectomy