Know Cancer

forgot password

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

Phase 2
35 Years
Open (Enrolling)
BRCA1 Mutation, BRCA2 Mutation

Thank you

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:


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:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Oscar Lambret


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

December 2011

Completion Date:

June 2019

Related Keywords:

  • BRCA1 Mutation
  • BRCA2 Mutation
  • BRCA1
  • BRCA2
  • Prophylactic surgery
  • Salpingectomy
  • Fimbriectomy