Actively Recruiting

Age: 18Years +
All Genders
NCT06111417

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

Led by Centre Georges Francois Leclerc · Updated on 2025-04-22

150

Participants Needed

2

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Indication for oncogenetic consultation with a wide panel test including BRCA1/2 as part of standard breast cancer management
  • Patient agrees to participate, follow all study procedures, and complete questionnaires during consultation or by email
  • Diagnosis of breast cancer within the last 6 months
  • Patient is affiliated with the social security system
Not Eligible

You will not qualify if you...

  • Any condition or disorder that may impair understanding of study information or questionnaire completion
  • No access to email, internet, or internet-capable devices
  • Pregnant, may become pregnant, or breastfeeding women
  • Persons deprived of liberty or under guardianship, including curatorship
  • Unable to attend study monitoring due to geographical, social, or psychological reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Centre Georges-François Leclerc

Dijon, France, 21000

Actively Recruiting

2

Institut Rafaël

Levallois-Perret, France, 92300

Actively Recruiting

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Research Team

M

Manon REDA, Dr

CONTACT

E

Emilie REDERSTORFF, Project Manager

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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