RecruitingNCT06111417

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

Sponsor

Centre Georges Francois Leclerc

Enrollment

150 participants

Start Date

Jun 12, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new ultra-rapid BRCA1/2 genetic screening test in breast cancer patients who need genetic testing for treatment planning. The goal is to see if this fast test performs as well as the standard genetic test and whether it benefits both patients and doctors. **You may be eligible if...** - You are 18 or older with a breast cancer diagnosis within the last 6 months - You have been recommended for genetic testing (including BRCA1/2) as part of your standard cancer care - You have access to email and internet, and are enrolled in the French social security system **You may NOT be eligible if...** - You have a condition that would prevent you from understanding the study or completing questionnaires - You do not have email access or internet - You are pregnant, may become pregnant, or are breastfeeding - You are deprived of liberty or under legal guardianship Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERQuestionnaires

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

OTHERCommunication 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

Locations(2)

Centre Georges-François Leclerc

Dijon, France

Institut Rafaël

Levallois-Perret, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06111417

Related Trials

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer

NCT034128771 location

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

NCT06982521158 locations

Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer

NCT0560144010 locations

Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast

NCT061297472 locations

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

NCT0661828764 locations