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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-12

Study Completion Date

2026-09-12

Brief Summary

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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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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard arm

Analysis carried out using the gold standard with BRCA1/2 results provided on average in 2 months for the theranostic analysis and 3 months for the "standard" analysis + ultrafast BRCA1/2 test (nanopore test) with no communication of results to the patient at 1-2 weeks.

Questionnaires

Intervention Type OTHER

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

Experimental arm

Analysis carried out using the gold standard with BRCA1/2 results provided in an average of 2 months for the theranostic analysis and 3 months for the "standard" analysis + ultra-rapid BRCA1/2 test (nanopore test) with results communicated to the patient in 1-2 weeks. This communication will be accompanied by the necessary explanations to enable the patient to understand that this is a preliminary result and that only the gold standard will constitute a definitive result.

Questionnaires

Intervention Type OTHER

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

Communication of the results of the BRCA1/2 ultra rapid test

Intervention Type OTHER

Communication of the results of the BRCA1/2 ultra rapid test during a consultation 1 to 2 weeks after the test

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No