Recruiting

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

ClinicalTrials.gov IDNCT06111417

PhaseNot Applicable

Enrollment150

SponsorCentre Georges Francois Leclerc

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

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.

Interventions

Other: 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
Other: 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

Primary outcomes

Compare the results obtained with an ultra-rapid kit BRCA1/2 with those obtained with the current gold standard, by checking the sensitivity, specificity and the rate of patients correctly classified for BRCA1 and 2 status (During 2 months)

Eligibility information

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.

Study locations

Centre Georges-François Leclerc, Dijon, 21000 France
Institut Rafaël, Levallois-Perret, 92300 France

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.