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Classifying genetic variants for cancer risk assessment

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

NA · Institut Curie · NCT01689584

This study is testing how to better understand certain genetic changes in cancer-related genes to help patients and their families make informed decisions about their cancer risk and treatment options.

Quick facts

PhaseNA
Study typeInterventional
Enrollment3500 (estimated)
Ages18 Years and up
SexAll
SponsorInstitut Curie (other)
Locations57 sites (Saint-Cloud, Haut de Seine and 56 other locations)
Trial IDNCT01689584 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who carry specific gene variants associated with cancer risk and their relatives.

Not a fit: Patients who are minors or those without a signed consent form will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with genetic predispositions to cancer.

How similar studies have performed: Other studies have shown success in classifying genetic variants, indicating that this approach is promising and builds on existing knowledge.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Saint-Cloud, Haut de Seine and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Gene Mutation-Related Cancer, Genetic Predisposition, BRCA1, BRCA2, VUS, co-segregation, genetic counseling, PALB2

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.