COsegregation of VARiants in Panel of Genes

NCT01689584 · tracked via the Priya Life Science France tracker

Sponsor

Institut Curie

Phase

Not applicable

Started

2012-07-02

Last updated

2026-09-01

Condition(s) studied

Gene Mutation-Related CancerGenetic Predisposition

Investigational drug(s) / intervention(s)

salivary kit

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

Study summary

The aim of the COVAR project is to achieve reliable classification of as many variants of interest as possible from the French OncoGenetics Database (FrOG, https://frog-db.fr/) 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Index cases: * A person carrying a variant of interest in a gene analyzed in a diagnostic setting by one of the laboratories within the Genetics and Cancer Group (GGC)-Unicancer network, classified as class 3, 4 or hypomorphic class 5, and selected by the national expert group for the gene concerned. * 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, selected by the investigators, according to family structure and degree of related compared to the index case * For class 4 and hypomorphic class 5 variants; relatives currently undergoing analysis or having already obtained a test result for the variant of interest as part of clinical care. * 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

Primary outcome measure(s)

Perform the co-segregation analysis of the selected VUS (class 3) or likely pathogenic variant (class 4) in the families. — up to 15 years
Number of variants classified using methods based on likelihood ratio estimation of the selected VUS (class 3) or likely pathogenic variant (class 4) in the families in order to classify the maximum of variants in terms of their probability to be pathogenic (class 5) or (likely) benign (class 1 and 2).

Trial sites (62)

Facility	City	Region	Status
Centre Hospitalier de Bastia	Bastia	Corsica	Not Yet Recruiting
Institut Curie - Saint-Cloud site	Saint-Cloud	Haut de Seine	Recruiting
CHU Amiens - Hôpital Nord	Amiens	France	Recruiting
ICO - Centre Paul Papin	Angers	France	Recruiting
Centre Hospitalier d'Angoulème	Angoulême	France	Recruiting
Institut Sainte-Catherine	Avignon	France	Recruiting
CHU Besançon	Besançon	France	Recruiting
Groupe Hospitalier Pellegrin	Bordeaux	France	Recruiting
Institut Bergonié	Bordeaux	France	Recruiting
Centre Hospitalier Jacques Coeur	Bourges	France	Recruiting
CHU Morvan de Brest	Brest	France	Recruiting
Centre François Baclesse	Caen	France	Recruiting
Centre Hospitalier Hôtel Dieu	Chambéry	France	Recruiting
Centre Jean Perrin	Clermont-Ferrand	France	Recruiting
Hôpital Civil de Colmar	Colmar	France	Not Yet Recruiting
CHU de Dijon	Dijon	France	Recruiting
CHU de Grenoble	Grenoble	France	Recruiting
CHD Vendée	La Roche-sur-Yon	France	Not Yet Recruiting
Groupe Hospitalier La Rochelle-Ré-Aunis	La Rochelle	France	Recruiting
Hôpital Flaubert	Le Havre	France	Recruiting
Centre Oscar Lambret	Lille	France	Recruiting
Chru Lille	Lille	France	Recruiting
CHU Dupuytren	Limoges	France	Recruiting
Hospices Civils de Lyon	Lyon	France	Recruiting
Centre Léon Bérard	Lyon	France	Recruiting
Institut Paoli Calmettes	Marseille	France	Recruiting
CHU La Timone	Marseille	France	Recruiting
CHU Arnaud de Villeneuve	Montpellier	France	Recruiting
Centre Catherine de Sienne	Nantes	France	Recruiting
Centre Antoine Lacassagne	Nice	France	Recruiting
Centre Hospitalier Georges Renon	Niort	France	Recruiting
CHRU Caremeau	Nîmes	France	Recruiting
Hôpital de la Source	Orléans	France	Recruiting
Hôpital Saint-Antoine	Paris	France	Recruiting
Groupe Hospitalier Pitié-Salpêtrière	Paris	France	Recruiting
Hôpital Tenon	Paris	France	Recruiting
Hôpital Saint-Louis	Paris	France	Recruiting
HEGP	Paris	France	Recruiting
Centre Hospitalier Intercommunal Poissy -Saint Germain-en-Laye	Poissy	France	Not Yet Recruiting
CHU La Milétrie	Poitiers	France	Recruiting

+ 22 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01689584 on ClinicalTrials.gov ↗ ← All trials in France