[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613628":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":10,"responsibleParty":35,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":10,"maxAge":10,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":10},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Adult AML cohort",null,"Adults ≥ 18 years with ELN-defined AML enrolled in DATAML Bordeaux, possessing flow-cytometry MRD data after induction and consolidation 1",[13,14],"Diagnostic Test: Conventional gating","Diagnostic Test: Automated gating",{"label":16,"type":10,"description":17,"interventionNames":18},"Paediatric AML cohort","Children and adolescents 0-18 years managed in the paediatric haemato-oncology unit, with analogous MRD flow-cytometry data",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","Conventional gating","Manual expert gating of multiparameter flow-cytometry data for MRD",[9,16],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Automated gating","Unsupervised FlowSOM gating of multiparameter flow-cytometry data for MRD",[9,16],[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Aguirre MIMOUN","CONTACT","05 57 65 60 98","aguirre.mimoun@chu-bordeaux.fr",{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100613628","automated-vs-manual-flow-cytometry-gating-for-measurable-residual-disease-in-acute-myeloid-leukaemia-dualflow-100613628",false,"NCT07269067","Automated vs Manual Flow-cytometry Gating for Measurable Residual Disease in Acute Myeloid Leukaemia (DUALFLOW)","Multicenter Retrospective Cohort Assessing Concordance Between Manual Gating and Unsupervised FlowSOM Gating for Minimal Residual Disease Detection by Multiparameter Flow Cytometry in Adult and Paediatric Acute Myeloid Leukaemia","DUALFLOW","Inclusion Criteria:\n\n* Confirmed diagnosis of acute myeloid leukaemia per ELN 2022\n* Age ≥ 18 years (adult cohort) or 0-20 years (paediatric cohort)\n* Inclusion in DATAML Bordeaux database or paediatric haemato-oncology records\n* Available flow-cytometry MRD data post-induction and post-consolidation 1\n* Non-opposition or consent for secondary use of data\n\nExclusion Criteria:\n\n* AML subtypes M3, M6 or M7\n* Acute leukaemia of ambiguous lineage\n* Missing or unusable flow-cytometry files for required time points","ALL",{"count":47,"type":48},60,"ESTIMATED","OBSERVATIONAL","This retrospective multicentre cohort evaluates the agreement of measurable residual disease (MRD) detection in acute myeloid leukaemia (AML) using two flow-cytometry gating approaches. Manual expert gating is compared with an unsupervised FlowSOM clustering algorithm across post-induction and post-consolidation samples from 50 adults and 10 paediatric patients treated at Bordeaux University Hospital. The primary hypothesis states that unsupervised gating detects MRD ≥ 0.1 % with sensitivity and specificity comparable to manual gating.",[52],"Leukemia, Myeloid, Acute",[54,55,56,57,58,59],"Acute Myeloid Leukemia","Minimal Residual Disease","Flow Cytometry","FlowSOM","Gating Algorithm","Machine Learning","NOT_YET_RECRUITING","2025-12-03",{"date":63,"type":64},"2025-12-08","ACTUAL",{"date":66,"type":48},"2026-01",{"date":68,"type":48},"2027-07",{"name":5,"class":6}]