Status:

RECRUITING

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

Lead Sponsor:

Centre Georges Francois Leclerc

Conditions:

Breast Cancer

Eligibility:

All Genders

18+ years

Brief 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 t...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 12 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 12 2026

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT06111417

Start Date

June 12 2024

End Date

September 12 2026

Last Update

April 22 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Centre Georges-François Leclerc

Dijon, France, 21000

2

Institut Rafaël

Levallois-Perret, France, 92300