[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524644":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":30,"armGroups":31,"interventions":42,"overallOfficials":26,"centralContacts":51,"locations":62,"responsibleParty":95,"collaborators":26,"id":97,"slug":26,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":26,"enrollmentInfo":105,"targetDuration":26,"studyType":108,"phases":26,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Centre Georges Francois Leclerc","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Compare the results obtained with an ultra-rapid kit BRCA1\u002F2 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.\n\n* True positives (VP) : patients presenting a BRCA 1 or 2 mutation with the ultrafast BRCA1\u002F2 test and the gold standard.\n* False positives (FP) : patients with a BRCA 1 or 2 mutation using the BRCA1\u002F2 ultrafast test and no BRCA 1 or 2 mutation using the gold standard.\n* True negatives (VN) : patients with no BRCA 1 or 2 mutation using the BRCA1\u002F2 ultrafast test and the gold standard.\n* False negatives (FN) : patients without a BRCA 1 or 2 mutation using the BRCA1\u002F2 ultrafast test and with a BRCA 1 or 2 mutation using the standard test.\n\nWELL 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\u002F2 test (nanopore test) is used exclusively instead of the gold standard. The overall number of misclassified patients must therefore be limited.","During 2 months",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Evaluate the sensitivity and specificity of the ultra-rapid BRCA1\u002F2 test","Evaluate the sensitivity and specificity of the ultra-rapid BRCA1\u002F2 test (nanopore test) compared with the standard BRCA1\u002F2 test (gold standard).",{"measure":18,"description":19,"timeFrame":12},"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:\n\n* After the patient has not objected to taking part in the TURBO study at the first consultation (before randomization);\n* 1-2 weeks after inclusion. The questionnaire will be e-mailed to patients. The questionnaire must be completed before the results of the BRCA1\u002F2 ultrafast test (nanopore test) are communicated to patients in the experimental group.\n* 4 weeks after inclusion. The questionnaire will be sent by email.\n* 8 - 12 weeks after inclusion, during the consultation for the communication of test results with the gold standard, before the communication of results.",{"measure":21,"description":22,"timeFrame":12},"Evaluate clinician satisfaction with satisfaction scale used in genetic counselling","Clinician satisfaction (oncogeneticist and oncologist) and acceptance of the BRCA1\u002F2 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:\n\n* When the first patient is unopposed;\n* At the last patient's discharge.",{"measure":24,"description":25,"timeFrame":12},"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:\n\n* After the patient has made no objection to participating in the TURBO study during the first consultation (before randomization);\n* 8 - 12 weeks after inclusion, before the consultation for the gold standard test results.",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"COHORT","PROSPECTIVE","Breast cancer with an indication for theranostic BRCA1\u002F2 analysis or diagnostic BRCA1\u002F2 analysis",[32,37],{"label":33,"type":26,"description":34,"interventionNames":35},"Standard arm","Analysis carried out using the gold standard with BRCA1\u002F2 results provided on average in 2 months for the theranostic analysis and 3 months for the \"standard\" analysis + ultrafast BRCA1\u002F2 test (nanopore test) with no communication of results to the patient at 1-2 weeks.",[36],"Other: Questionnaires",{"label":38,"type":26,"description":39,"interventionNames":40},"Experimental arm","Analysis carried out using the gold standard with BRCA1\u002F2 results provided in an average of 2 months for the theranostic analysis and 3 months for the \"standard\" analysis + ultra-rapid BRCA1\u002F2 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.",[36,41],"Other: Communication of the results of the BRCA1\u002F2 ultra rapid test",[43,47],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":26},"Questionnaires","3 questionnaires to allowed to assess satisfaction and acceptance of the nanopore ultrafast test by practitioners and anxiety of results by patients :\n\n* STAI-Y (State-Trait Anxiety Inventory)\n* Patient's Questionnaire\n* Practitioner's questionnaire",[38,33],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":26},"Communication of the results of the BRCA1\u002F2 ultra rapid test","Communication of the results of the BRCA1\u002F2 ultra rapid test during a consultation 1 to 2 weeks after the test",[38],[52,58],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Manon REDA, Dr","CONTACT","03.80.73.75.00","+33","mreda@cgfl.fr",{"name":59,"role":54,"phone":60,"phoneExt":56,"email":61},"Emilie REDERSTORFF, Project Manager","03 45 34 81 16","erederstorff@cgfl.fr",[63,81],{"facility":64,"status":65,"city":66,"state":26,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Centre Georges-François Leclerc","RECRUITING","Dijon","21000","France","FR",{"type":71,"coordinates":72},"Point",[73,74],5.01391,47.31344,{"lat":74,"lon":73},[77,79],{"name":53,"role":54,"phone":78,"phoneExt":26,"email":57},"03 80 73 75 00",{"name":80,"role":54,"phone":60,"phoneExt":26,"email":61},"Emilie REDERSTORFF",{"facility":82,"status":65,"city":83,"state":26,"zip":84,"country":68,"countryCode":69,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Institut Rafaël","Levallois-Perret","92300",{"type":71,"coordinates":86},[87,88],2.28864,48.89389,{"lat":88,"lon":87},[91],{"name":92,"role":54,"phone":93,"phoneExt":26,"email":94},"Pascal PUJOL, Pr","01 84 00 70 07","p-pujol@chu-montpellier.fr",{"type":96,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100524644",false,"NCT06111417","Use of an Ultra-rapid BRCA1\u002F2 Status Screening Test in Diagnostic and Theranostic Indication: Performance and Interest for Patients and Practitioners","TURBO","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Indication for oncogenetic consultation with a wide panel test including BRCA1\u002F2 (gold standard) as part of the standard theranostic and diagnostic management of breast cancer.\n* 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.\n* Diagnosis of the disease ≤ 6 months\n* The patient must be affiliated to the social security system.\n\nExclusion Criteria:\n\n* Concomitant disorder or condition likely to compromise understanding of study information or completion of questionnaires\n* Patients who do not have an email address and\u002For do not have internet access or tools to connect to the internet\n* Women who are pregnant, may become pregnant or are breast-feeding\n* Persons deprived of their liberty or under guardianship (including curatorship)\n* Inability to undergo trial monitoring for geographical, social or psychological reasons.","ALL","18 Years",{"count":106,"type":107},150,"ESTIMATED","OBSERVATIONAL","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.\n\nThe time taken to obtain the results of BRCA1\u002F2 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.\n\nThe 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.",[111],"Breast Cancer",[113,114],"BRCA 1\u002F2","breast cancer","2025-04-17",{"date":117,"type":118},"2025-04-22","ACTUAL",{"date":120,"type":118},"2024-06-12",{"date":122,"type":107},"2026-09-12",{"name":5,"class":6},2]