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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard arm | Analysis carried out using the gold standard with BRCA1/2 results provided on average in 2 months for the theranostic analysis and 3 months for the "standard" analysis + ultrafast BRCA1/2 test (nanopore test) with no communication of results to the patient at 1-2 weeks. |
| |
| Experimental arm | Analysis carried out using the gold standard with BRCA1/2 results provided in an average of 2 months for the theranostic analysis and 3 months for the "standard" analysis + ultra-rapid BRCA1/2 test (nanopore test) with results communicated to the patient in 1-2 weeks. This communication will be accompanied by the necessary explanations to enable the patient to understand that this is a preliminary result and that only the gold standard will constitute a definitive result. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | 3 questionnaires to allowed to assess satisfaction and acceptance of the nanopore ultrafast test by practitioners and anxiety of results by patients :
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| To assess the impact on patients' mental well-being (anxiety or reassurance) using the State-Trait Anxiety Questionnaire (STAI-Y) |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer with an indication for theranostic BRCA1/2 analysis or diagnostic BRCA1/2 analysis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manon REDA, Dr | Contact | 03.80.73.75.00 | +33 | mreda@cgfl.fr |
| Emilie REDERSTORFF, Project Manager | Contact | 03 45 34 81 16 | +33 | erederstorff@cgfl.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges-FranƧois Leclerc | Recruiting | Dijon | 21000 | France |
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| Communication of the results of the BRCA1/2 ultra rapid test | Other | Communication of the results of the BRCA1/2 ultra rapid test during a consultation 1 to 2 weeks after the test |
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Anxiety will be assessed in each arm using the State-Trait Anxiety Questionnaire (STAI-Y) at 4 different time points:
|
| During 2 months |
| 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:
| During 2 months |
| 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:
| During 2 months |
| Institut Rafaƫl | Recruiting | Levallois-Perret | 92300 | France |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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