Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma
35 Years
N/A
Female
BRCA1 Mutation, BRCA2 Mutation
Trial Information
Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Rate of pelvic cancer
Outcome Description:
Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause
Outcome Time Frame:
an expected average of 15 years
Safety Issue:
No
Principal Investigator
Eric LEBLANC, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Oscar Lambret
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
FIMBRIECTOMIE
NCT ID:
NCT01608074
Start Date:
December 2011
Completion Date:
June 2019
Related Keywords:
- BRCA1 Mutation
- BRCA2 Mutation
- BRCA1
- BRCA2
- Prophylactic surgery
- Salpingectomy
- Fimbriectomy
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