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
  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

Resource links provided by NLM:


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


Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2016 (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
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
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

Contacts
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

Locations
France
Polyclinique du Parc Rambot Recruiting
Aix en Provence, France, 13626
Contact: Véronique VAINI-COWEN, MD    0442574706    dr.vve@wanadoo.fr   
Principal Investigator: Véronique VAINI-COWEN         
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Bénédicte BENETREAU, CRA    0556330483    b-benetreau@bordeaux-unicancer.fr   
Principal Investigator: Anne FLOQUET, MD         
Centre Hospitalier Universitaire Lyon Recruiting
Bron, France, 69 674
Contact: Patrice MATHEVET, MD PhD    +33 (0)4.72.35.58.84    patrice.mathevet@chu-lyon.fr   
Principal Investigator: Patrice MATHEVET, MD PhD         
Sub-Investigator: Philippe CHABERT, MD         
Sub-Investigator: Sophie GIRAUD, MD         
Centre Jean Perrin Recruiting
Clermont-ferrand, France, 63011
Contact: Christophe POMEL, MD    04.73.27.81.21    christophe.pomel@cjp.fr   
Principal Investigator: Christophe POMEL, MD         
Sub-Investigator: Emilie MONRIGAL, MD         
Sub-Investigator: Guillaume LE BOUEDEC, MD         
Sub-Investigator: Jean-Yves BIGNON, MD         
Clinique du Parc Recruiting
Croix, France, 59963
Contact: Frédéric CAQUANT, MD    03 20 83 21 98    frederic.caquant@mac.com   
Principal Investigator: Frédéric CACQUANT, MD         
Sub-Investigator: Sébastien RAULT, MD         
Sub-Investigator: Philippe VENNIN, MD         
CHR-U Not yet recruiting
Lille, France, 59045
Contact: Pierre COLLINET, MD    33 320446388    Pierre.collinet@chru-lille.fr   
Principal Investigator: Pierre COLLINET, MD         
Centre Oscar Lambret Recruiting
Lille, France, 59000
Contact: Eric LEBLANC, MD    +33 (0)3 20 29 59 18    e-leblanc@o-lambret.fr   
Contact: Yvette VENDEL, CRA    03.20.29.59.40    y-vendel@o-lambret.fr   
Principal Investigator: Eric LEBLANC, MD         
Sub-Investigator: Fabrice NARDUCCI, MD         
Sub-Investigator: Claude ADENIS, MD         
Sub-Investigator: Philippe VENNIN, MD         
Clinique du Bois - Bourgogne Center Recruiting
Lille, France, 59 000
Contact: Jean-Yves CHARVOLIN, MD    +33 (0)3.20.09.24.34    charvolin@charvolin.com   
Principal Investigator: Jean-Yves CHARVOLIN, MD         
Sub-Investigator: Patricia MAES, MD         
Sub-Investigator: Dominique CATHELINEAU, MD         
Sub-Investigator: Philippe VENNIN, MD         
Hospices Civils de Lyon Not yet recruiting
Lyon, France, 69
Contact: Laurent VILLENEUVE, MD    0478864396    laurent.villeneuve@chu-lyon.fr   
Principal Investigator: François GOLFIER         
Institut Paoli Calmettes Recruiting
Marseille, France, 13273
Contact: Gilles HOUVENAGHEL, MD, PhD    04 91 22 35 32    houvenag@marseille.fnclcc.fr   
Principal Investigator: Gilles HOUVENAEGHEL, MD, PhD         
Sub-Investigator: Eric LAMBAUDIE, MD         
Sub-Investigator: Marie BANNIER, MD         
Sub-Investigator: Max BUTTARELLI, MD         
Sub-Investigator: Virginia MICHEL, MD         
Centre René Gauducheau Recruiting
Nantes Saint-herblain, France, 44805
Contact: Virginie BORDES, MD    02 40 67 99 59    virginie.bores@ico.unicancer.fr   
Principal Investigator: Virginie BORDES, MD         
Sub-Investigator: Jean-Marc CLASSE, MD         
Sub-Investigator: Capucine DELNATTE, MD         
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Christine Lovera, CRA    04 92 03 16 18    christine.lovera@nice.unicancer.fr   
Principal Investigator: Véronique MARI, MD         
Institut Curie Recruiting
Paris, France, 75005
Contact: Anne BLONDEL, CRA    0144324686    anne.blondel@curie.net   
Principal Investigator: Virginie Fourchotte, MD         
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Fabrice LECURU, MD, PhD    01 56 09 35 84    fabrice.lecuru@egp.aphp.fr   
Principal Investigator: Fabrice LECURU, MD, PhD         
Sub-Investigator: Anne-Sophie BATS, MD         
Sub-Investigator: Bensaid CHAHRAZED, MD         
Sub-Investigator: Pierre LAURENT PUIG, MD         
Hôpital Tenon Recruiting
Paris, France, 75020
Contact: Simon TABASSONNE, CRA    0156017318    tabassonne.simon@tnn-aphp.fr   
Principal Investigator: Emile DARAI, MD, PhD         
Institut Jean Godinot Recruiting
Reims, France, 51056
Contact: Véronique DANGMANN, CRA    0326504184    veronique.dangmann@reims-unicancer.fr   
Principal Investigator: Aude Marie SAVOYE, MD         
Centre Eugène Marquis Recruiting
Rennes, France, 35042
Contact: Jean LEVEQUE, MD, PhD    02 99 25 31 99    jean.leveque@fnclcc.fr   
Principal Investigator: Jean LEVEQUE, MD, PhD         
Sub-Investigator: Catherine DUGAS, MD         
CHU Charles Nicolle Recruiting
Rouen, France, 76000
Contact: Benoît RESCH, MD    02 32 88 87 54    benoit.resch@chu-rouen.fr   
Principal Investigator: Benoît RESCH, MD         
Sub-Investigator: Loïc MARPEAU, MD PhD         
Sub-Investigator: Alexis GROMEZ, MD         
Sub-Investigator: Thierry FREBOURG, MD PhD         
Sub-Investigator: Julie TINAT, MD         
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Contact: Louis Ferdinand PEPIN, MD    0232082544    louis-ferdinand-pepin@chb-unicancer.fr   
Principal Investigator: Marc BARON, MD         
Institut Claudius Regaud Recruiting
Toulouse, France, 31059
Contact: Mélanie LEBEGUE, CRA    0557222556    lebegue.melanie@claudius-regaud.fr   
Principal Investigator: Denis Querleu, MD, PhD         
CHU Bretonneau Recruiting
Tours, France, 37044
Contact: Henri MARRET, MD, PhD    02 47 47 82 59    marret@med.univ-tours.fr   
Principal Investigator: Henri MARRET, MD, PhD         
Sub-Investigator: Lobna OULDAMER, MD         
Sub-Investigator: Isabelle MORTEMOUSQUE, MD         
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Chrystel COULOMB, CRA    0142114332    Chrystel.COULOMB@igr.fr   
Principal Investigator: Catherine UZAN         
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Eric LEBLANC, MD Centre Oscar Lambret
  More Information

No publications provided

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: March 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 16, 2014