[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524644":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":28,"locations":39,"responsibleParty":72,"collaborators":10,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":10,"enrollmentInfo":83,"targetDuration":10,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Centre Georges Francois Leclerc","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard arm",null,"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.",[13],"Other: Questionnaires",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13,18],"Other: Communication of the results of the BRCA1\u002F2 ultra rapid test",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"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",[15,9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"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",[15],[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Manon REDA, Dr","CONTACT","03.80.73.75.00","+33","mreda@cgfl.fr",{"name":36,"role":31,"phone":37,"phoneExt":33,"email":38},"Emilie REDERSTORFF, Project Manager","03 45 34 81 16","erederstorff@cgfl.fr",[40,58],{"facility":41,"status":42,"city":43,"state":10,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Centre Georges-François Leclerc","RECRUITING","Dijon","21000","France","FR",{"type":48,"coordinates":49},"Point",[50,51],5.01391,47.31344,{"lat":51,"lon":50},[54,56],{"name":30,"role":31,"phone":55,"phoneExt":10,"email":34},"03 80 73 75 00",{"name":57,"role":31,"phone":37,"phoneExt":10,"email":38},"Emilie REDERSTORFF",{"facility":59,"status":42,"city":60,"state":10,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Institut Rafaël","Levallois-Perret","92300",{"type":48,"coordinates":63},[64,65],2.28864,48.89389,{"lat":65,"lon":64},[68],{"name":69,"role":31,"phone":70,"phoneExt":10,"email":71},"Pascal PUJOL, Pr","01 84 00 70 07","p-pujol@chu-montpellier.fr",{"type":73,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100524644","use-of-an-ultra-rapid-brca12-status-screening-test-in-diagnostic-and-theranostic-indication-performance-and-interest-for-patients-and-practitioners-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":84,"type":85},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.",[89],"Breast Cancer",[91,92],"BRCA 1\u002F2","breast cancer","2025-04-17",{"date":95,"type":96},"2025-04-22","ACTUAL",{"date":98,"type":96},"2024-06-12",{"date":100,"type":85},"2026-09-12",{"name":5,"class":6},2]