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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

RECRUITINGSponsored by Centre Georges Francois Leclerc
Actively Recruiting
SponsorCentre Georges Francois Leclerc
Started2024-06-12
Est. completion2026-09-12
Eligibility
Age18 Years+
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

Breast CancerCancer

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