Breast Cancer
Conditions
Keywords
BRCA 1/2, breast cancer
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 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.
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
Sponsors
Centre Georges Francois Leclerc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | During 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the sensitivity and specificity of the ultra-rapid BRCA1/2 test | During 2 months | Evaluate the sensitivity and specificity of the ultra-rapid BRCA1/2 test (nanopore test) compared with the standard BRCA1/2 test (gold standard). |
| To assess the impact on patients' mental well-being (anxiety or reassurance) using the State-Trait Anxiety Questionnaire (STAI-Y) | During 2 months | 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 - 12 weeks after inclusion, during the consultation for the communication of test results with the gold standard, before the communication of results. |
| Evaluate clinician satisfaction with satisfaction scale used in genetic counselling | During 2 months | 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. |
| Evaluate patient satisfaction used in genetic counselling | During 2 months | 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 - 12 weeks after inclusion, before the consultation for the gold standard test results. |
Countries
France
Contacts
Primary ContactManon REDA, Dr
Backup ContactEmilie REDERSTORFF, Project Manager
Outcome results
None listed