[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659713":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":27,"overallOfficials":32,"centralContacts":37,"locations":13,"responsibleParty":47,"collaborators":13,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":13,"enrollmentInfo":59,"targetDuration":13,"studyType":62,"phases":63,"briefSummary":64,"conditions":65,"keywords":13,"overallStatus":69,"whyStopped":13,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":13},{"fullName":5,"class":6},"Gruppo Italiano Malattie EMatologiche dell'Adulto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Prognostic risk classification","Proportion of patients whose prognostic risk classification according to the ELN2022 criteria (Favorable\u002FLow-risk, Intermediate\u002FIntermediate-risk, Adverse\u002FHigh-risk) is concordant between the investigational method RAMD and GSS, to demonstrate non-inferiority of RAMD versus GSS.","at 24 months",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","SCREENING",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Prospective, multicenter study for the non-inferiority assessment of RAMD compared to GSS in determining the prognostic risk category according to ELN2022 for newly diagnosed AML patients.\n\nThe blood sample from bone marrow (BM) (or PB) for test RAMD, will be collected by the participating centers at diagnosis together with the sample for GSS. The gold-standard tests will be performed on the diagnostic sample at the collecting center according to local procedures, whereas the diagnostic sample for RAMD, as frozen WBCs pellet, will be processed upon arrival at the Central Laboratory according to the RAMD protocol. The results of GSS and RAMD will be entered independently into the eCRF as soon as they become available and subsequently compared for the purposes of the study.",[22],{"label":23,"type":6,"description":24,"interventionNames":25},"Non-inferiority assessment of RAMD compared to GSS","The blood sample from bone marrow (or PB) will be collected at diagnosis for test RAMD",[26],"Other: Bone marrow or peripheral blood withdrawal for test comparison",[28],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":13},"Bone marrow or peripheral blood withdrawal for test comparison","The blood sample from bone marrow (BM) (or PB) for test RAMD will be collected by the participating centers at diagnosis. The gold-standard tests (GSS) will be performed according to local procedures, whereas the diagnostic sample for RAMD, as frozen WBCs pellet, will be processed upon arrival at the Central Laboratory. The results of GSS and RAMD will be subsequently compared.",[23],[33],{"name":34,"affiliation":35,"role":36},"Niccolo Bartalucci","AOU Careggi CRIMM LAB Firenze","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":13,"email":42},"Paola Fazi","CONTACT","00390670390528","p.fazi@gimema.it",{"name":44,"role":40,"phone":45,"phoneExt":13,"email":46},"Enrico Crea","00390670390514","e.crea@gimema.it",{"type":48,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659713","feasibility-and-efficiency-study-for-the-implementation-of-a-new-screening-method-for-patients-with-acute-myeloid-leukemia-in-laboratory-practice-100659713",false,"NCT07867704","Feasibility and Efficiency Study for the Implementation of a New Screening Method for Patients With Acute Myeloid Leukemia, in Laboratory Practice","Feasibility and Efficiency Study for the Implementation of a New Screening Method for Patients With Acute Myeloid Leukemia, in Laboratory Practice RAMD (Rapid AML Mutations Detection)","RAMD","Inclusion Criteria:\n\n1. Patients with de novo AML, includind Acute Promyelocytic Leukemia (APL), untreated, newly diagnosed according to WHO\u002FICC 2022 criteria based on conventional cytological, cytogenetic, and immunophenotypic disease characterization\n2. Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws.\n3. Availability of 1 aliquot of White Blood Cells pellet (≥3x106 WBCs or purified from ≥1.5mL of blood) from bone marrow (BM) or peripheral blood (PB) collected at diagnosis for RAMD. The aliquot should be stored at -90°C until shipment.\n4. Age ≥ 18 years\n\nExclusion Criteria:\n\n1\\. Diagnosis of secondary AML","ALL","18 Years",{"count":60,"type":61},75,"ESTIMATED","INTERVENTIONAL",[15],"Prospective, multicenter study for the non-inferiority assessment of RAMD compared to GSS in determining the prognostic risk category according to ELN2022 for newly diagnosed AML patients on blood samples.",[66,67,68],"Acute Myeloid Leukemia","Acute Myeloid Leukemia, Adult","Acute Promyelocytic Leukemia","NOT_YET_RECRUITING","2026-10-05",{"date":72,"type":73},"2026-10-09","ACTUAL",{"date":75,"type":61},"2027-01",{"date":77,"type":61},"2029-01",{"name":5,"class":6}]