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

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

NCT ID: NCT06111417

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
BRCA 1/2
breast cancer

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Questionnaires
Description: 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
Arm group label: Experimental arm
Arm group label: Standard arm

Intervention type: Other
Intervention name: Communication of the results of the BRCA1/2 ultra rapid test
Description: Communication of the results of the BRCA1/2 ultra rapid test during a consultation 1 to 2 weeks after the test
Arm group label: Experimental arm

Summary: 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.

Criteria for eligibility:

Study pop:
Breast cancer with an indication for theranostic BRCA1/2 analysis

Sampling method: Non-Probability Sample
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 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: April 1, 2024

Completion date: June 1, 2026

Lead sponsor:
Agency: Centre Georges Francois Leclerc
Agency class: Other

Source: Centre Georges Francois Leclerc

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06111417