Overview

This trial is active, not recruiting.

Conditions brca1 mutation, brca2 mutation
Treatments radical fimbriectomy, histopathology see-fim
Phase phase 2
Sponsor Centre Oscar Lambret
Start date December 2011
End date October 2017
Trial size 123 participants
Trial identifier NCT01608074, FIMBRIECTOMIE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer. Radical fimbriectomy. Histopathology SEE-FIM
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)
histopathology see-fim Sectioning and Extensively Examining the FIMbria
Anatomopathological study of surgical specimens

Primary Outcomes

Measure
Rate of pelvic cancer
time frame: an expected average of 15 years

Secondary Outcomes

Measure
Morbidity associated with the radical prophylactic fimbriectomy
time frame: Up to 30 days after the surgery
Rate of occult lesions on fimbriectomy specimens
time frame: Within 1 month after surgery
Incidence of breast cancer or recurrence of breast cancer
time frame: an expected average of 15 years
Rate of secondary oophorectomies and associated morbidity
time frame: an expected average of 15 years

Eligibility Criteria

Female participants at least 35 years old.

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

Additional Information

Official title Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma
Principal investigator Eric LEBLANC, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Centre Oscar Lambret.