Clinical Research Directory
Browse clinical research sites, groups, and studies.
Use of an Ultra-rapid BRCA1/2 Status Screening Test in Diagnostic and Theranostic Indication: Performance and Interest for Patients and Practitioners
Sponsor: Centre Georges Francois Leclerc
Summary
The time taken to obtain the results of germline mutations in BRCA1 and BRCA2 has become a major issue in adapting the therapeutic management of patients, particularly those with breast cancer. The time taken to obtain the results of BRCA1/2 tests in routine laboratories with a view to personalised treatment can range from a few weeks to a few months. The waiting time required to obtain results is likely to cause stress and anxiety in cancer patients. The investigators hypothesise that ultra-rapid testing can reduce anxiety about patients' genetic status and improve their mental well-being. The main objective of this project is to compare the results obtained with an ultra-fast kit developed by O.N.T with those obtained with the current gold standard, NGS sequencing.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2024-06-12
Completion Date
2026-09-12
Last Updated
2025-04-22
Healthy Volunteers
No
Conditions
Interventions
Questionnaires
3 questionnaires to allowed to assess satisfaction and acceptance of the nanopore ultrafast test by practitioners and anxiety of results by patients : * STAI-Y (State-Trait Anxiety Inventory) * Patient's Questionnaire * Practitioner's questionnaire
Communication of the results of the BRCA1/2 ultra rapid test
Communication of the results of the BRCA1/2 ultra rapid test during a consultation 1 to 2 weeks after the test
Locations (2)
Centre Georges-François Leclerc
Dijon, France
Institut Rafaël
Levallois-Perret, France