Ultra-rapid testing for BRCA1/2 mutations in breast cancer patients
Official title: Use of an Ultra-rapid BRCA1/2 Status Screening Test in Diagnostic and Theranostic Indication: Performance and Interest for Patients and Practitioners
Run by Centre Georges Francois Leclerc · NCT06111417 · Data updated 2026-11-12
This study tests a fast BRCA1/2 mutation screening for breast cancer patients to see if it can reduce their waiting time for results and help ease their anxiety.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Centre Georges Francois Leclerc Academic / other |
| Locations | 2 sites (Dijon and 1 other locations) |
| Status | Recruiting |
| Started | June 12, 2024 |
| Main results expected | September 12, 2026 |
| Study ends | September 12, 2026 |
| Registry record updated | April 22, 2025 |
| Trial ID | NCT06111417 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have been diagnosed with breast cancer within the last six months and require oncogenetic consultation for BRCA1/2 testing.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or unable to complete study procedures due to various reasons may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of an ultra-rapid BRCA1/2 mutation screening test compared to the traditional NGS sequencing method. It aims to reduce the waiting time for test results, which can cause significant anxiety for breast cancer patients. By utilizing a fast-testing kit developed by O.N.T, the study seeks to improve patient mental well-being and facilitate timely therapeutic management. Participants will complete questionnaires to assess their experiences and the impact of rapid testing on their anxiety levels.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety and improve the mental well-being of breast cancer patients awaiting genetic test results.
How similar studies have gone: While the concept of rapid genetic testing is emerging, this specific approach has not been widely tested, making it a novel initiative.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Indication for oncogenetic consultation with a wide panel test including BRCA1/2 (gold standard) as part of the standard theranostic and diagnostic management of breast cancer. * The patient agrees to take part in the study, to follow all the study procedures and to complete the questionnaires sent during the consultation or by email. * Diagnosis of the disease ≤ 6 months * The patient must be affiliated to the social security system. Exclusion Criteria: * Concomitant disorder or condition likely to compromise understanding of study information or completion of questionnaires * Patients who do not have an email address and/or do not have internet access or tools to connect to the internet * Women who are pregnant, may become pregnant or are breast-feeding * Persons deprived of their liberty or under guardianship (including curatorship) * Inability to undergo trial monitoring for geographical, social or psychological reasons.
Where it's running
-
Centre Georges-François Leclerc
Dijon, France Recruiting -
Institut Rafaël
Levallois-Perret, France Recruiting
Study contacts
- Study coordinator: Manon REDA, Dr
- Email: mreda@cgfl.fr
- Phone: 03.80.73.75.00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.