Breast CancerTURBONCT06111417
Use of an Ultra-rapid BRCA1/2 Status Screening Test in Diagnostic and Theranostic Indication: Performance and Interest for Patients and Practitioners
An observational study of Breast Cancer, run by Centre Georges Francois Leclerc at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaires and Communication of the results of the BRCA1/2 ultra rapid test
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Jun 2024to 12 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer with an indication for theranostic BRCA1/2 analysis or diagnostic BRCA1/2 analysis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Georges-François Leclerc
Dijon, 21000
Manon REDA, Dr, 03 80 73 75 00, mreda@cgfl.fr
Emilie REDERSTORFF, 03 45 34 81 16, erederstorff@cgfl.fr
- Recruiting
Institut Rafaël
Levallois-Perret, 92300
Pascal PUJOL, Pr, 01 84 00 70 07, p-pujol@chu-montpellier.fr
About this study
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
- Breast Cancer
- Being tested
- Questionnaires, Communication of the results of the BRCA1/2 ultra rapid test
- Keywords
- BRCA 1/2, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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 testOther
Communication of the results of the BRCA1/2 ultra rapid test during a consultation 1 to 2 weeks after the test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires | |
| 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. Receives: Other: Questionnaires; Other: Communication of the results of the BRCA1/2 ultra rapid test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 2 months
Secondary outcomes (4)
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).
Measured: During 2 months
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 - 12 weeks after inclusion, during the consultation for the communication of test results with the gold standard, before the communication of results.
Measured: 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:
- When the first patient is unopposed;
- At the last patient's discharge.
Measured: 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:
- 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.
Measured: During 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start12 Jun 2024
- Primary completion12 Sep 2026 (estimated)
- Study completion12 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111417
- Sponsor's protocol ID
- 2023-A02176-39
- Acronym
- TURBO
- Status last verified
- Apr 2025
- First submitted
- 20 Oct 2023
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Ultra-rapid BRCA1/2 Status Screening Test in Diagnostic and Theranostic Indication: Performance and Interest for Patients and Practitioners
- ClinicalTrials.gov ID
- NCT06111417
- Acronym / sponsor ID
- TURBO / 2023-A02176-39
- Conditions
- Breast Cancer
- Keywords
- BRCA 1/2, breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 12 Sep 2026 (estimated)
- Study completion
- 12 Sep 2026 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm | – | Other: QuestionnairesAnalysis 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 | – | Other: Questionnaires, Other: Communication of the results of the BRCA1/2 ultra rapid testAnalysis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer with an indication for theranostic BRCA1/2 analysis or diagnostic BRCA1/2 analysis
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires3 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 | Other | Experimental arm, Standard arm |
| Communication of the results of the BRCA1/2 ultra rapid testCommunication of the results of the BRCA1/2 ultra rapid test during a consultation 1 to 2 weeks after the test | Other | Experimental arm |
Primary outcome
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
Time frame: 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.
4 secondary outcomes
Evaluate the sensitivity and specificity of the ultra-rapid BRCA1/2 test
Time frame: During 2 months
To assess the impact on patients' mental well-being (anxiety or reassurance) using the State-Trait Anxiety Questionnaire (STAI-Y)
Time frame: During 2 months
Evaluate clinician satisfaction with satisfaction scale used in genetic counselling
Time frame: During 2 months
Evaluate patient satisfaction used in genetic counselling
Time frame: During 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centre Georges Francois Leclerc at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon REDA, Dr (03.80.73.75.00 ext. +33, mreda@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: During 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.