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

Recruitingn/aAges 18 Years - anyAllCentre Georges Francois Leclerc
NCT06111417 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Questionnaires
  • Communication of the results of the BRCA1/2 ultra rapid test
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Where

2 sites
Centre Georges-François Leclerc
Dijon, France
Institut Rafaël
Levallois-Perret, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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