Radical Fimbriectomy for Young BRCA Mutation Carriers

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01608074
First received: May 15, 2012
Last updated: March 5, 2014
Last verified: August 2013

May 15, 2012
March 5, 2014
December 2011
June 2016   (final data collection date for primary outcome measure)
Rate of pelvic cancer [ Time Frame: an expected average of 15 years ] [ Designated as safety issue: No ]
Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause
Same as current
Complete list of historical versions of study NCT01608074 on ClinicalTrials.gov Archive Site
  • Morbidity associated with the radical prophylactic fimbriectomy [ Time Frame: Up to 30 days after the surgery ] [ Designated as safety issue: Yes ]
    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
  • Rate of occult lesions on fimbriectomy specimens [ Time Frame: Within 1 month after surgery ] [ Designated as safety issue: No ]
    Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens
  • Incidence of breast cancer or recurrence of breast cancer [ Time Frame: an expected average of 15 years ] [ Designated as safety issue: No ]
    Number of cases of breast cancer or breast cancer recurrence observed
  • Rate of secondary oophorectomies and associated morbidity [ Time Frame: an expected average of 15 years ] [ Designated as safety issue: No ]
    Number of oophorectomies and time between fimbriectomy and oophorectomy Complications according to NCI-CTCAE v4.0 grading scale
Same as current
Not Provided
Not Provided
 
Radical Fimbriectomy for Young BRCA Mutation Carriers
Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma

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.

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

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Procedure: 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)

  • Other: Histopathology SEE-FIM
    Anatomopathological study of surgical specimens
    Other Name: Sectioning and Extensively Examining the FIMbria
Experimental: BRCA mutation carriers
Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer
Interventions:
  • Procedure: Radical fimbriectomy
  • Other: Histopathology SEE-FIM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2019
June 2016   (final data collection date for primary outcome measure)

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
Female
35 Years and older
No
Contact: Eric LEBLANC, MD 03 20 29 59 18 e-leblanc@o-lambret.fr
Contact: Yvette VENDEL, CRA 03.20.29.59.40 y-vendel@o-lambret.fr
France
 
NCT01608074
FIMBRIECTOMIE
Yes
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Principal Investigator: Eric LEBLANC, MD Centre Oscar Lambret
Centre Oscar Lambret
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP