Use of an Ultra-rapid BRCA1/2 Status Screening Test in Diagnostic and Theranostic Indication: Performance and Interest for Patients and Practitioners

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.

NCT Number	NCT06111417
Lead Sponsor	Centre Georges Francois Leclerc
Conditions	Breast Cancer
Enrollment	150 participants
Start Date	2024-06-12
Primary Completion	2026-09-12 (estimated)
Study Completion	2026-09-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-22