Actively Recruiting
Use of an Ultra-rapid BRCA1/2 Status Screening Test in Diagnostic and Theranostic Indication: Performance and Interest for Patients and Practitioners
Led by Centre Georges Francois Leclerc · Updated on 2025-04-22
150
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of an Ultra-rapid BRCA1/2 Status Screening Test in Diagnostic and Theranostic Indication: Performance and Interest for Patients and Practitioners
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Indication for oncogenetic consultation with a wide panel test including BRCA1/2 as part of standard breast cancer management
- Patient agrees to participate, follow all study procedures, and complete questionnaires during consultation or by email
- Diagnosis of breast cancer within the last 6 months
- Patient is affiliated with the social security system
You will not qualify if you...
- Any condition or disorder that may impair understanding of study information or questionnaire completion
- No access to email, internet, or internet-capable devices
- Pregnant, may become pregnant, or breastfeeding women
- Persons deprived of liberty or under guardianship, including curatorship
- Unable to attend study monitoring due to geographical, social, or psychological reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Centre Georges-François Leclerc
Dijon, France, 21000
Actively Recruiting
2
Institut Rafaël
Levallois-Perret, France, 92300
Actively Recruiting
Research Team
M
Manon REDA, Dr
CONTACT
E
Emilie REDERSTORFF, Project Manager
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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