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COsegregation of VARiants in Panel of Genes (COVAR)

Primary Purpose

Gene Mutation-Related Cancer, Genetic Predisposition

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

salivary kit

About this trial

This is an interventional diagnostic trial for Gene Mutation-Related Cancer focused on measuring BRCA1, BRCA2, VUS, co-segregation, genetic counseling, PALB2, panel of genes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Index cases:

A person carrying a gene variant class 3 or 4, present and selected in the families of national database of genetic group and cancer (GGC Unicancer) which identifies the variations of all genes from the panel of genes of all French laboratories.
Age ≥ 18 years.
Signed written inform consent "index case"

Related parties:

Any relative of an index case with cancer
Any relative without cancer related to an index case, retained by investigators, based on family structure and degree of related compared to the index case
Age ≥ 18 years
Information and signature of the informed consent "selected relatives"

Exclusion Criteria:

Minors
Persons deprived of liberty or under guardianship (including curators).
Absence of signed written inform consent

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Covar

Arm Description

Outcomes

Primary Outcome Measures

Perform the co-segregation analysis of the selected VUS in the families in order to classify the maximum of variants in terms of their probability to be pathogenic

Secondary Outcome Measures

• Propose a standardized method to classify VUS that can be integrated into the already existing classification established in the UMD-BRCA1/2 database, with the main focus on variants of class 4 (probably causal) and class 3 (unknown significance).

• Maximize the number of VUS (both pathogenic and neutral) having associated recommendations for clinical management of at-risk relatives that can be used to guide genetic counselling.

Assess the penetrance of several class 3 and 4 VUS probably associated with moderate cancer risk, using collected phenotype/genotype data on extended pedigrees.

Full Information

NCT ID

NCT01689584

First Posted

May 14, 2012

Last Updated

September 1, 2022

Sponsor

Institut Curie

1. Study Identification

Unique Protocol Identification Number

NCT01689584

Brief Title

COsegregation of VARiants in Panel of Genes

Acronym

COVAR

Official Title

Study of Family COsegregation of Nucleotide VARiants in the Panel of Genes to Validate Their Use in Genetic Counseling

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 2012 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Curie

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the COVAR project is to classify reliably a maximum of VUS of the French database in order to use them for the genetic counseling. The results obtained through this study will have a major impact on clinical management of the patients and their families conducting in some cases to propose a prophylactic surgery.

Detailed Description

Originally, the COVAR study was designed to explore Variants of unknown biological significance (VUS) in BRCA1 (BReast Cancer 1) and BRCA2 (BReast Cancer 2) genes, which are the two major genes identified in hereditary breast and/or ovarian cancers. Since then the study has evolved, in parallel with the evolution of diagnosis, first introducing the PALB2 (Partner and localizer of BRCA2) gene explored in diagnosis since 2015 and now opening the study to all the genes of the panels performed in diagnosis in families with a genetic predisposition syndrome to cancers. The French UMD (Universal Mutation Database)-BRCA1/2, accredited by the French National Cancer Institute, collects anonymous results of genetic tests performed by authorized French laboratories since 1995, giving a real-time vision of families carrying the same VUS. In september 2011, the French UMD-BRCA1/2 database comprised 706 different variants in 1,300 BRCA1 families and 1,089 different variants in 2,101 BRCA2 families. In April 2021, this database contained 1,651 different VSU for BRCA1, 3,015 different VUS for BRCA2, 471 different VUS for PALB2, 68 for RAD51C and 66 for RAD51D. Since 2017, new genes have been explored in the diagnostic setting as they have been reported as predisposing factors for cancers. This list is constantly evolving (Moretta et al., 2018; Dhooge et al., 2020). Data collection for these genes is ongoing and a new database (FrOG) gathering all VUS and mutations identified in the French oncogenetic network has been set up. We have set up a consortium agreement at the end of 2020. This database gathers to date 12 genes and 11,912 different variants in more than 40,000 French families. One of the key measurable parameters for classification of VUS as causal mutations is their co-segregation with the disease. The average size of French families is relatively small, the information of variant co-segregation limited to one family would not be significant. However, the compilation of co-segregation results obtained from several families will allow to obtain more precise and complete estimations of the probability of causality of a given variant. The objective of the COVAR study (COsegregation VARiants) is to organize co-segregation studies of the VUS of the database UMD-BRCA1/2, in order to determine the causal or non-causal nature of these variants. To organize the variants by their clinical relevance, a grid with 5 classes has been used: 1=neutral, 2=likely neutral, 3=VUS, 4=likely causal, 5=causal. The VUS of classes 3 and 4 will be candidates to co-segregation studies because they cannot be used for the genetic counseling. In the selected families the index case will invite the family members (affected and unaffected) to provide a sample of salivary fluid to test the presence of the VUS. The probability that a VUS is causal will be calculated from the cosegregation data using a Bayesian model. The results will be integrated in the multifactorial model described by D. Goldgar, model integrating different parameters as amino acid conservation, structural impact of the variant, co-occurrence with a pathogenic mutation, family history and tumor characteristics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gene Mutation-Related Cancer, Genetic Predisposition

Keywords

BRCA1, BRCA2, VUS, co-segregation, genetic counseling, PALB2, panel of genes

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Covar

Arm Type

Other

Intervention Type

Genetic

Intervention Name(s)

salivary kit

Intervention Description

The saliva samples will be made of selected related (DNA).

Primary Outcome Measure Information:

Title

Perform the co-segregation analysis of the selected VUS in the families in order to classify the maximum of variants in terms of their probability to be pathogenic

Time Frame

up to 15 years

Secondary Outcome Measure Information:

Title

Time Frame

up to 15 years

Title

• Maximize the number of VUS (both pathogenic and neutral) having associated recommendations for clinical management of at-risk relatives that can be used to guide genetic counselling.

Time Frame

up to 15 years

Title

Assess the penetrance of several class 3 and 4 VUS probably associated with moderate cancer risk, using collected phenotype/genotype data on extended pedigrees.

Time Frame

up to 15 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Index cases: A person carrying a gene variant class 3 or 4, present and selected in the families of national database of genetic group and cancer (GGC Unicancer) which identifies the variations of all genes from the panel of genes of all French laboratories. Age ≥ 18 years. Signed written inform consent "index case" Related parties: Any relative of an index case with cancer Any relative without cancer related to an index case, retained by investigators, based on family structure and degree of related compared to the index case Age ≥ 18 years Information and signature of the informed consent "selected relatives" Exclusion Criteria: Minors Persons deprived of liberty or under guardianship (including curators). Absence of signed written inform consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sandrine CAPUTO, PhD

Phone

33172389367

sandrine.caputo@curie.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Isabelle TURBIEZ, Project Manager

Phone

33147111659

isabelle.turbiez@curie.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominique STOPPA-LYONNET, PU-PH

Organizational Affiliation

Institut Curie

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Sandrine CAPUTO, PhD

Organizational Affiliation

Institut Curie

Official's Role

Study Director

Facility Information:

Facility Name

Institut Curie - Hopital Rene Huguenin

City

Saint-Cloud

State/Province

Haut De Seine

ZIP/Postal Code

92210

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emmanuelle FOURME, PhD

emmanuelle.fourme@curie.fr

First Name & Middle Initial & Last Name & Degree

Emmanuelle FOURME, MD

Facility Name

Institut Curie

City

Paris

State/Province

Ile De France

ZIP/Postal Code

75005

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandrine CAPUTO, PhD

sandrine.caputo@curie.fr

First Name & Middle Initial & Last Name & Degree

Dominique STOPPA-LYONNET, PU-PH

Facility Name

CHU Amiens - Hôpital Nord

City

Amiens

ZIP/Postal Code

80054

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gilles MORIN, MD

First Name & Middle Initial & Last Name & Degree

Gilles MORIN, MD

Facility Name

ICO - Centre Paul Papin

City

Angers

ZIP/Postal Code

49933

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier INGSTER, MD

First Name & Middle Initial & Last Name & Degree

Olivier INGSTER, MD

Facility Name

Centre Hospitalier d'Angoulème

City

Angoulême

ZIP/Postal Code

16959

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul GESTA, MD

First Name & Middle Initial & Last Name & Degree

Paul GESTA, MD

Facility Name

Institut Sainte-Catherine

City

Avignon

ZIP/Postal Code

84918

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hélène DREYFUS, MD

First Name & Middle Initial & Last Name & Degree

Hélène DREYFUS, MD

Facility Name

CHU Besançon

City

Besancon

ZIP/Postal Code

25030

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie-Agnès COLLONGE-RAME, MD

First Name & Middle Initial & Last Name & Degree

Marie-Agnès COLLONGE-RAME, MD

Facility Name

Groupe Hospitalier Pellegrin

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julie TINAT, MD

First Name & Middle Initial & Last Name & Degree

Julie TINAT, MD

Facility Name

Institut Bergonié

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Virginie BUBIEN, MD

First Name & Middle Initial & Last Name & Degree

Virginie BUBIEN, MD

Facility Name

Centre Hospitalier Jacques Coeur

City

Bourges

ZIP/Postal Code

18020

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle MORTEMOUSQUE, MD

First Name & Middle Initial & Last Name & Degree

Isabelle MORTEMOUSQUE, MD

Facility Name

CHU Morvan de Brest

City

Brest

ZIP/Postal Code

29200

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc PLANES, MD

First Name & Middle Initial & Last Name & Degree

Marc PLANES, MD

Facility Name

Centre François Baclesse

City

Caen

ZIP/Postal Code

14076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascaline BERTHET, MD

First Name & Middle Initial & Last Name & Degree

Pascaline BERTHET, MD

Facility Name

Centre Hospitalier Hôtel Dieu

City

Chambery

ZIP/Postal Code

73011

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandra FERRER, MD

First Name & Middle Initial & Last Name & Degree

Sandra FERRER, MD

Facility Name

Centre Jean Perrin

City

Clermont-Ferrand

ZIP/Postal Code

63011

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yves-Jean BIGNON, PhD

First Name & Middle Initial & Last Name & Degree

Yves-Jean BIGNON, PhD

Facility Name

Hôpital Civil de Colmar

City

Colmar

ZIP/Postal Code

68024

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Marc LIMACHER

First Name & Middle Initial & Last Name & Degree

Jean-Marc LIMACHER, MD

Facility Name

CHU de Dijon

City

Dijon

ZIP/Postal Code

21079

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurence FAIVRE-OLIVIER, MD

First Name & Middle Initial & Last Name & Degree

Laurence FAIVRE-OLIVIER, MD

Facility Name

CHU de Grenoble

City

Grenoble

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clémentine LEGRAND, MD

First Name & Middle Initial & Last Name & Degree

Clémentine LEGRAND, MD

Facility Name

Groupe Hospitalier La Rochelle-Ré-Aunis

City

La Rochelle

ZIP/Postal Code

17019

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul GESTA, MD

First Name & Middle Initial & Last Name & Degree

Paul GESTA, MD

Facility Name

Hôpital Flaubert

City

Le Havre

ZIP/Postal Code

76083

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elodie LACAZE, MD

First Name & Middle Initial & Last Name & Degree

Elodie LACAZE, MD

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Audrey MAILLIEZ, MD

First Name & Middle Initial & Last Name & Degree

Audrey MAILLIEZ, MD

Facility Name

Chru Lille

City

Lille

ZIP/Postal Code

59037

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie LEJEUNE, MD

First Name & Middle Initial & Last Name & Degree

Sophie LEJEUNE, MD

Facility Name

CHU Dupuytren

City

Limoges

ZIP/Postal Code

87042

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurence VENAT-BOUVET, MD

First Name & Middle Initial & Last Name & Degree

Laurence VENAT-BOUVET, MD

Facility Name

Hospices Civils de Lyon

City

Lyon

ZIP/Postal Code

69229

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie GIRAUD, MD

First Name & Middle Initial & Last Name & Degree

Sophie GIRAUD, MD

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69373

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine LASSET, MD

First Name & Middle Initial & Last Name & Degree

Christine LASSET, MD

Facility Name

Institut Paoli Calmettes

City

Marseille

ZIP/Postal Code

13009

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hagay SOBOL, PhD

First Name & Middle Initial & Last Name & Degree

Hagay SOBOL, PhD

Facility Name

CHU La Timone

City

Marseille

ZIP/Postal Code

13385

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hélène ZATTARA, MD

First Name & Middle Initial & Last Name & Degree

Hélène ZATTARA, MD

Facility Name

CHU Arnaud de Villeneuve

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle COUPIER, MD

First Name & Middle Initial & Last Name & Degree

Isabelle COUPIER, MD

Facility Name

Centre Catherine de Sienne

City

Nantes

ZIP/Postal Code

44202

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alain LORTHOLARY, MD

First Name & Middle Initial & Last Name & Degree

Alain LORTHOLARY, MD

Facility Name

Centre Antoine Lacassagne

City

Nice

ZIP/Postal Code

06189

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Véronique MARI, MD

First Name & Middle Initial & Last Name & Degree

Véronique MARI, MD

Facility Name

Centre Hospitalier Georges Renon

City

Niort

ZIP/Postal Code

79021

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul GESTA, MD

First Name & Middle Initial & Last Name & Degree

Paul GESTA, MD

Facility Name

CHRU Caremeau

City

Nîmes

ZIP/Postal Code

30029

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean CHIESA, MD

First Name & Middle Initial & Last Name & Degree

Jean CHIESA, MD

Facility Name

Hôpital de la Source

City

Orléans

ZIP/Postal Code

45067

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

E COTTEREAU, MD

First Name & Middle Initial & Last Name & Degree

E COTTEREAU, MD

Facility Name

Hôpital Saint-Antoine

City

Paris

ZIP/Postal Code

75012

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antoine DARDENNE, MD

First Name & Middle Initial & Last Name & Degree

Antoine DARDENNE, MD

Facility Name

Groupe Hospitalier Pitié-Salpêtrière

City

Paris

ZIP/Postal Code

75013

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick BENUSIGLIO, MD

First Name & Middle Initial & Last Name & Degree

Patrick BENUSIGLIO, MD

Facility Name

Hôpital Tenon

City

Paris

ZIP/Postal Code

75020

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick BENUSIGLIO, MD

First Name & Middle Initial & Last Name & Degree

Patrick BENUSIGLIO, MD

Facility Name

Hôpital Saint-Louis

City

Paris

ZIP/Postal Code

75475

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Odile COHEN-HAGUENAUER, MD

First Name & Middle Initial & Last Name & Degree

Odile COHEN-HAGUENAUER, MD

Facility Name

HEGP

City

Paris

ZIP/Postal Code

75908

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre-Laurent PUIG, Phd

First Name & Middle Initial & Last Name & Degree

Pierre-Laurent PUIG, Phd

Facility Name

CHU La Milétrie

City

Poitiers

ZIP/Postal Code

86021

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul GESTA, MD

First Name & Middle Initial & Last Name & Degree

Paul GESTA, MD

Facility Name

CHU de Reims

City

Reims

ZIP/Postal Code

51092

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne DURLACH, MD

First Name & Middle Initial & Last Name & Degree

Anne DURLACH, MD

Facility Name

ICC Courlancy

City

Reims

ZIP/Postal Code

51100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fanny BRAYOTEL, MD

First Name & Middle Initial & Last Name & Degree

Fanny BRAYOTEL, MD

Facility Name

Institut Jean Godinot

City

Reims

ZIP/Postal Code

51100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tan Dat NGUYEN, PHD

First Name & Middle Initial & Last Name & Degree

Tan Dat NGUYEN, PHD

Facility Name

Centre Eugène Marquis

City

Rennes

ZIP/Postal Code

35042

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Louise CRIVELLI, MD

First Name & Middle Initial & Last Name & Degree

Louise CRIVELLI, MD

Facility Name

CHU de Rouen

City

Rouen

ZIP/Postal Code

76031

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle TENNEVET, MD

First Name & Middle Initial & Last Name & Degree

Isabelle TENNEVET, MD

Facility Name

ICO - Centre René Gauducheau

City

Saint-Herblain

ZIP/Postal Code

44804

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Capucine DELNATTE, MD

First Name & Middle Initial & Last Name & Degree

Capucine DELNATTE, MD

Facility Name

CHU Saint Etienne

City

Saint-Étienne

ZIP/Postal Code

42055

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabienne PRIEUR, MD

First Name & Middle Initial & Last Name & Degree

Fabienne PRIEUR, MD

Facility Name

Institut de Cancérologie Strasbourg Europe ICANS

City

Strasbourg

ZIP/Postal Code

67033

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cynthia DENIS, MD

First Name & Middle Initial & Last Name & Degree

Cynthia DENIS, MD

Facility Name

Hopital de Hautepierre - Hôpital Universitaire

City

Strasbourg

ZIP/Postal Code

67200

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine MAUGARD, MD

First Name & Middle Initial & Last Name & Degree

Christine MAUGARD, MD

Facility Name

Institut Claudius Regaud - IUCT - Oncopole

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurence GLADIEFF, MD

First Name & Middle Initial & Last Name & Degree

Laurence GLADIEFF, MD

Facility Name

CHU Bretonneau

City

Tours

ZIP/Postal Code

37044

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle MORTEMOUSQUE, MD

First Name & Middle Initial & Last Name & Degree

Isabelle MORTEMOUSQUE, MD

Facility Name

CH Simone VEIL

City

Troyes

ZIP/Postal Code

10003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charlotte CAILLE-BENIGNI, MD

First Name & Middle Initial & Last Name & Degree

Charlotte CAILLE-BENIGNI, MD

Facility Name

Centre Hospitalier de Valence

City

Valence

ZIP/Postal Code

26953

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie-Noëlle BONNET-DUPEYRON, MD

First Name & Middle Initial & Last Name & Degree

Marie-Noëlle BONNET-DUPEYRON, MD

Facility Name

Centre Alexis Vautrin

City

Vandoeuvre les Nancy

ZIP/Postal Code

54511

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elisabeth LUPORSI, MD

Facility Name

CHU Nancy - Hôpital Brabois

City

Vandoeuvre les Nancy

ZIP/Postal Code

54511

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie MULLER, MD

First Name & Middle Initial & Last Name & Degree

Marie MULLER, MD

Facility Name

Gustave Roussy

City

Villejuif

ZIP/Postal Code

94805

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier CARON, MD

First Name & Middle Initial & Last Name & Degree

Olivier CARON, MD

Facility Name

CHU de Pointe à Pitre

City

Pointe à Pitre

ZIP/Postal Code

97110

Country

Guadeloupe

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marilyn LACKMY-PORT-LIS, MD

First Name & Middle Initial & Last Name & Degree

Marilyn LACKMY-PORT-LIS, MD

Facility Name

CHU de Fort de France

City

Fort de France

ZIP/Postal Code

97261

Country

Martinique

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Odile BERA, MD

First Name & Middle Initial & Last Name & Degree

Odile BERA, MD

Facility Name

CHU Sud Réunion Saint-Pierre

City

Saint-Pierre

ZIP/Postal Code

97410

Country

Réunion

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hanitra RANJATOELINA, MD

First Name & Middle Initial & Last Name & Degree

Hanitra RANJATOELINA, MD

12. IPD Sharing Statement

Links:

URL

http://www.umd.be/BRCA1/

Description

French BRCA1 database

URL

http://www.umd.be/BRCA2/

Description

French BRCA2 database

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COsegregation of VARiants in Panel of Genes

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COsegregation of VARiants in Panel of Genes (COVAR)

Gene Mutation-Related Cancer, Genetic Predisposition

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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