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Radical Fimbriectomy for Young BRCA Mutation Carriers (Fimbriectomy)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608074
First Posted: May 30, 2012
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Oscar Lambret
May 15, 2012
May 30, 2012
July 21, 2017
December 2011
October 2019   (Final data collection date for primary outcome measure)
Rate of pelvic cancer [ Time Frame: an expected average of 15 years ]
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 ]
    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 ]
    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 ]
    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 ]
    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
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Hereditary Breast and Ovarian Cancer
  • 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.

Radical fimbriectomy. Histopathology SEE-FIM

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.
 
Active, not recruiting
123
October 2025
October 2019   (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
Sexes Eligible for Study: Female
35 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01608074
FIMBRIECTOMIE
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Principal Investigator: Eric LEBLANC, MD Centre Oscar Lambret
Centre Oscar Lambret
July 2017

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