Radical Fimbriectomy for Young BRCA Mutation Carriers (Fimbriectomy)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01608074
First received: May 15, 2012
Last updated: February 15, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
BRCA1 Mutation
BRCA2 Mutation
Procedure: Radical fimbriectomy
Other: Histopathology SEE-FIM
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 123
Study Start Date: December 2011
Estimated Study Completion Date: December 2027
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BRCA mutation carriers

Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer.

Radical fimbriectomy. Histopathology SEE-FIM

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

Detailed 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

  Eligibility

Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608074

Locations
France
Polyclinique du Parc Rambot
Aix en Provence, France, 13626
Institut Bergonié
Bordeaux, France, 33076
Centre Hospitalier Universitaire Lyon
Bron, France, 69 674
Centre Jean Perrin
Clermont-ferrand, France, 63011
Clinique du Parc
Croix, France, 59963
Clinique du Bois - Bourgogne Center
Lille, France, 59 000
Centre Oscar Lambret
Lille, France, 59000
CHR-U
Lille, France, 59045
Hospices Civils de Lyon
Lyon, France, 69
Institut Paoli Calmettes
Marseille, France, 13273
Centre René Gauducheau
Nantes Saint-herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
Institut Curie
Paris, France, 75005
Hôpital Européen Georges Pompidou
Paris, France, 75015
Hôpital Tenon
Paris, France, 75020
Institut Jean Godinot
Reims, France, 51056
Centre Eugène Marquis
Rennes, France, 35042
Centre Henri Becquerel
Rouen, France, 76000
CHU Charles Nicolle
Rouen, France, 76000
Institut Claudius Regaud
Toulouse, France, 31059
CHU Bretonneau
Tours, France, 37044
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Eric LEBLANC, MD Centre Oscar Lambret
  More Information

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01608074     History of Changes
Other Study ID Numbers: FIMBRIECTOMIE 
Study First Received: May 15, 2012
Last Updated: February 15, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Centre Oscar Lambret:
BRCA1
BRCA2
Prophylactic surgery
Salpingectomy
Fimbriectomy

ClinicalTrials.gov processed this record on July 25, 2016