COsegregation of VARiants in Panel of Genes
COVAR
Study of Family COsegregation of Nucleotide VARiants in the Panel of Genes to Validate Their Use in Genetic Counseling
1 other identifier
interventional
3,500
4 countries
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2012
CompletedStudy Start
First participant enrolled
July 2, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 2, 2034
April 6, 2025
March 1, 2025
20.5 years
May 14, 2012
April 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
up to 15 years
Secondary Outcomes (3)
• 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).
up to 15 years
• 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.
up to 15 years
Assess the penetrance of several class 3 and 4 VUS probably associated with moderate cancer risk, using collected phenotype/genotype data on extended pedigrees.
up to 15 years
Study Arms (1)
Covar
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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"
You may not qualify if:
- Minors
- Persons deprived of liberty or under guardianship (including curators).
- Absence of signed written inform consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Curielead
Study Sites (57)
Institut Curie - Hopital Rene Huguenin
Saint-Cloud, Haut de Seine, 92210, France
CHU Amiens - Hôpital Nord
Amiens, 80054, France
ICO - Centre Paul Papin
Angers, 49933, France
Centre Hospitalier d'Angoulème
Angoulême, 16959, France
Institut Sainte-Catherine
Avignon, 84918, France
CHU Besançon
Besançon, 25030, France
Groupe Hospitalier Pellegrin
Bordeaux, 33076, France
Institut Bergonié
Bordeaux, 33076, France
Centre Hospitalier Jacques Coeur
Bourges, 18020, France
CHU Morvan de Brest
Brest, 29200, France
Centre François Baclesse
Caen, 14076, France
Centre Hospitalier Hôtel Dieu
Chambéry, 73011, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Hôpital Civil de Colmar
Colmar, 68024, France
CHU de Dijon
Dijon, 21079, France
CHU de Grenoble
Grenoble, 38043, France
Groupe Hospitalier La Rochelle-Ré-Aunis
La Rochelle, 17019, France
Hôpital Flaubert
Le Havre, 76083, France
Centre Oscar Lambret
Lille, 59000, France
Chru Lille
Lille, 59037, France
CHU Dupuytren
Limoges, 87042, France
Hospices Civils de Lyon
Lyon, 69229, France
Centre Léon Bérard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13009, France
CHU La Timone
Marseille, 13385, France
CHU Arnaud de Villeneuve
Montpellier, 34295, France
Centre Catherine de Sienne
Nantes, 44202, France
Centre Antoine Lacassagne
Nice, 06189, France
Centre Hospitalier Georges Renon
Niort, 79021, France
CHRU Caremeau
Nîmes, 30029, France
Hôpital de la Source
Orléans, 45067, France
Hôpital Saint-Antoine
Paris, 75012, France
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013, France
Hôpital Tenon
Paris, 75020, France
Hôpital Saint-Louis
Paris, 75475, France
HEGP
Paris, 75908, France
CHU La Milétrie
Poitiers, 86021, France
CHU de Reims
Reims, 51092, France
ICC Courlancy
Reims, 51100, France
Institut Jean Godinot
Reims, 51100, France
Centre Eugène Marquis
Rennes, 35042, France
CHU de Rouen
Rouen, 76031, France
CHU Saint Etienne
Saint-Etienne, 42055, France
ICO - Centre René Gauducheau
Saint-Herblain, 44804, France
Institut de Cancérologie Strasbourg Europe ICANS
Strasbourg, 67033, France
Hopital de Hautepierre - Hôpital Universitaire
Strasbourg, 67200, France
Institut Claudius Regaud - IUCT - Oncopole
Toulouse, 31059, France
CHU Bretonneau
Tours, 37044, France
CH Simone VEIL
Troyes, 10003, France
Centre Hospitalier de Valence
Valence, 26953, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
CHU Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy, 54511, France
Gustave Roussy
Villejuif, 94805, France
Institut Curie
Paris, Île-de-France Region, 75005, France
CHU de Pointe à Pitre
Pointe-à-Pitre, 97110, Guadeloupe
CHU de Fort de France
Fort-de-France, 97261, Martinique
CHU Sud Réunion Saint-Pierre
Saint-Pierre, 97410, Reunion
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dominique STOPPA-LYONNET, PU-PH
Institut Curie
- STUDY DIRECTOR
Sandrine CAPUTO, PhD
Institut Curie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2012
First Posted
September 21, 2012
Study Start
July 2, 2012
Primary Completion (Estimated)
January 2, 2033
Study Completion (Estimated)
January 2, 2034
Last Updated
April 6, 2025
Record last verified: 2025-03