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

Breast Cancer Clinical Trial

— TURBO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06111417
• Other study ID #: 2023-A02176-39
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: February 2024
• Source: Centre Georges Francois Leclerc
• Contact: Manon REDA, Dr
• Phone: 03.80.73.75.00
• Email: mreda[@]cgfl.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the results obtained with an ultra-rapid kit BRCA1/2 with those obtained with the current gold standard, by checking the sensitivity, specificity and the rate of patients correctly classified for BRCA1 and 2 status	The main objective will be to determine the rate of misclassified patients by pooling the 2 arms, false positives and false negatives.; True positives (VP) : patients presenting a BRCA 1 or 2 mutation with the ultrafast BRCA1/2 test and the gold standard.; False positives (FP) : patients with a BRCA 1 or 2 mutation using the BRCA1/2 ultrafast test and no BRCA 1 or 2 mutation using the gold standard.; True negatives (VN) : patients with no BRCA 1 or 2 mutation using the BRCA1/2 ultrafast test and the gold standard.; False negatives (FN) : patients without a BRCA 1 or 2 mutation using the BRCA1/2 ultrafast test and with a BRCA 1 or 2 mutation using the standard test.; WELL classified = VP + VN, poorly classified= FP+ FN FPs will generate anxiety, and FNs will lead to a loss of chance for patients if the ultrafast BRCA1/2 test (nanopore test) is used exclusively instead of the gold standard. The overall number of misclassified patients must therefore be limited.	During 2 months
Secondary	Evaluate the sensitivity and specificity of the ultra-rapid BRCA1/2 test	Evaluate the sensitivity and specificity of the ultra-rapid BRCA1/2 test (nanopore test) compared with the standard BRCA1/2 test (gold standard).	During 2 months
Secondary	To assess the impact on patients' mental well-being (anxiety or reassurance) using the State-Trait Anxiety Questionnaire (STAI-Y)	Anxiety will be assessed in each arm using the State-Trait Anxiety Questionnaire (STAI-Y) at 4 different time points: After the patient has not objected to taking part in the TURBO study at the first consultation (before randomization); 1-2 weeks after inclusion. The questionnaire will be e-mailed to patients. The questionnaire must be completed before the results of the BRCA1/2 ultrafast test (nanopore test) are communicated to patients in the experimental group.; 4 weeks after inclusion. The questionnaire will be sent by email.; 8 weeks after inclusion, during the consultation for the communication of test results with the gold standard, before the communication of results.	During 2 months
Secondary	Evaluate clinician satisfaction with satisfaction scale used in genetic counselling	Clinician satisfaction (oncogeneticist and oncologist) and acceptance of the BRCA1/2 ultrafast test (nanopore test) will be evaluated in both arms using a questionnaire to assess clinician satisfaction at 2 different times for each practitioner involved in patient follow-up: When the first patient is unopposed; At the last patient's discharge.	During 2 months
Secondary	Evaluate patient satisfaction used in genetic counselling	Patient satisfaction will be assessed in both arms using a satisfaction scale used in genetic counselling at two different times: After the patient has made no objection to participating in the TURBO study during the first consultation (before randomization); 8 weeks after inclusion, before the consultation for the gold standard test results.	During 2 months