Classifying genetic variants for cancer risk assessment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The COVAR project aims to classify variants of unknown significance (VUS) in the BRCA1, BRCA2, and other cancer-related genes to enhance genetic counseling for patients and their families. By utilizing a comprehensive database of genetic tests, the study seeks to provide real-time insights into the implications of these variants for cancer predisposition. Participants will provide saliva samples for genetic analysis, which will help determine the clinical management strategies, including potential prophylactic surgeries for at-risk individuals.

Why it matters

Who can join: the full rules

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

Where it's running

• Institut Curie - Saint-Cloud site
  Saint-Cloud, Haut de Seine, France 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

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Sandrine CAPUTO, PhD
• Email: sandrine.caputo@curie.fr
• Phone: 33172389367

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.