[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396191":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":16,"studyPopulation":67,"armGroups":68,"interventions":86,"overallOfficials":91,"centralContacts":100,"locations":109,"responsibleParty":291,"collaborators":16,"id":293,"slug":16,"hasResults":294,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":294,"sex":299,"minAge":300,"maxAge":16,"enrollmentInfo":301,"targetDuration":304,"studyType":305,"phases":16,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":112,"whyStopped":16,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},{"fullName":5,"class":6},"Arbeitsgemeinschaft medikamentoese Tumortherapie","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"To assess the treatment patterns (therapeutic landscape) of patients with myeloid diseases.","Due to the non-interventional nature of the aMYELOIDr, treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions\u002Fescalations shall be exclusively based on the risk\u002Fbenefit estimation of the treating physician. We recommend compliance current guidelines.","Through study completion, median expected within 100 months",[14,17,19,22,25,28,31,34,37,39,41,43,45,48,51],{"measure":15,"description":16,"timeFrame":12},"Impact of front-line treatment on overall survival (OS)",null,{"measure":18,"description":16,"timeFrame":12},"Impact of number and choice of treatment lines on OS as of initial diagnosis and\u002For as of treatment start",{"measure":20,"description":21,"timeFrame":12},"Overall response rate (ORR)","Response will be assessed according to current guidelines for the respective disease. Due to the non-interventional nature of the aMYELOIDr, timepoints and types of response assessment shall be exclusively based on the risk\u002Fbenefit estimation of the treating physician. We recommend compliance current guidelines.",{"measure":23,"description":24,"timeFrame":12},"Event free survival (EFS)","Events include treatment failure, progressive disease, relapse after CR\u002FCRi, death from any cause. Patients lost to-follow-up or still alive ans without event will be censored at last follow-up date",{"measure":26,"description":27,"timeFrame":12},"AML transformation","Time to transformation to AML for patients with a non-AML initial diagnosis",{"measure":29,"description":30,"timeFrame":12},"Treatment safety","Investigators should report adverse reactions (for which a causal role of a medicine is suspected) to the concerned competent authorities following regulations in the current or future versions of Austrian legislation (Pharmakovigilanz-Verordnung 2013 (PhVO, Regulation on Pharmacovigilance), Österreichisches Arzneimittel Gesetz (AMG, Austrian Medicinal Products Act). Participation in this registry does not exempt the participating center from their legal reporting obligations. Documentation of causality, duration, frequency and severity of adverse events (AEs) according to Common Terminology Criteria for AE (CTCAE v.5).",{"measure":32,"description":33,"timeFrame":12},"Concomitant treatments","Concomitant treatments (number of administration of e.g. prophylactic antibiotics, antivirals, antifungals)",{"measure":35,"description":36,"timeFrame":12},"Treatment characteristics","Among others, the following treatment characteristics will be assessed for each treatment line: substance",{"measure":35,"description":38,"timeFrame":12},"Among others, the following treatment characteristics will be assessed for each treatment line: application date",{"measure":35,"description":40,"timeFrame":12},"Among others, the following treatment characteristics will be assessed for each treatment line: route",{"measure":35,"description":42,"timeFrame":12},"Among others, the following treatment characteristics will be assessed for each treatment line: dose",{"measure":35,"description":44,"timeFrame":12},"Among others, the following treatment characteristics will be assessed for each treatment line: inpatient or outpatient setting",{"measure":46,"description":47,"timeFrame":12},"Concomitant treatments best supportive care (BSC)","Concomitant best supportive care (BSC) measures (e.g. number of transfusions, growth factors, iron chelators)",{"measure":49,"description":50,"timeFrame":12},"Quality of life assessment EQ-5D-5L (optional)","EuroQol-5 Dimensions with 5 Levels. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his\u002Fher health state by ticking the box next to the most appropriate statement in each of the five dimensions.",{"measure":52,"description":53,"timeFrame":12},"EORTC Quality of life assessment QLQ-C30 (optional)","European Organisation for Research and Treatment of Cancer Quality of life 30-item questionnaire of cancer patients incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status \u002F QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation anddiarrhoea) and perceived financial impact of the disease. It has four-point scale which are coded with \"Not at all\", \"A little\", \"Quite a bit\" and \"Very much\"",[55,58,61],{"measure":56,"description":57,"timeFrame":12},"Minimal residual disease","Assess how many and which patients in Austria have minimal residual disease (MRD) assessments, assessed by which techniques and at which timepoints.",{"measure":59,"description":60,"timeFrame":12},"MRD-negativity on OS","Assess the impact of MRD-negativity on OS. MRD assessment via flow-cytometry and polymerase chain reactions according to the current ELN guidelines 2017 shall be exclusively based on the risk\u002Fbenefit estimation of the treating physician.",{"measure":62,"description":63,"timeFrame":12},"Prognostic and predictive markers","Analyses of various factors known or thought to influence OS, ORR, EFS, PFS and time to next treatment in order to validate existing or establish novel prognostic and predictive markers",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":65,"timePerspective":66,"maskingInfo":16},"COHORT","PROSPECTIVE","Patients with AML, MDS, CMML or PMF according to WHO 2016 diagnostic criteria",[69,74,78,82],{"label":70,"type":16,"description":71,"interventionNames":72},"AML","Patients with WHO 2016 diagnosis of AML",[73],"Other: Non-interventional",{"label":75,"type":16,"description":76,"interventionNames":77},"MDS","Patients with WHO 2016 diagnosis of MDS",[73],{"label":79,"type":16,"description":80,"interventionNames":81},"CMML","Patients with WHO 2016 diagnosis of CMML",[73],{"label":83,"type":16,"description":84,"interventionNames":85},"PMF","Patients with WHO 2016 diagnosis of PMF",[73],[87],{"type":6,"name":88,"description":89,"armGroupLabels":90,"otherNames":16},"Non-interventional","Only routine clinical data, which has already been recorded in the patient's medical chart, will be documented. Any other data assessments (e.g. quality of life analyses such as EQ-5D and QLQ-C30 have been approved by the Ehtikkommission für das Bundesland Salzburg and are optional.",[70,79,75,83],[92,96],{"name":93,"affiliation":94,"role":95},"Richard Greil, MD","AGMT gemeinnützige GmbH","STUDY_CHAIR",{"name":97,"affiliation":98,"role":99},"Lisa Pleyer, MD","3rd Med Dept Paracelsus Medical University, Salzburg","PRINCIPAL_INVESTIGATOR",[101,105],{"name":97,"role":102,"phone":103,"phoneExt":16,"email":104},"CONTACT","+43676899758271","dr.lisa.pleyer@gmail.com",{"name":106,"role":102,"phone":107,"phoneExt":16,"email":108},"Daniela Wolkersdorfer","+436626404412","office@agmt.at",[110,126,138,148,160,172,184,196,205,214,225,237,249,261,270,279],{"facility":111,"status":112,"city":113,"state":16,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"LKH Feldkirch, Innere Medizin II, Interne E: Hämatologie und Onkologie","RECRUITING","Feldkirch","6807","Austria","AT",{"type":118,"coordinates":119},"Point",[120,121],9.59734,47.23645,{"lat":121,"lon":120},[124],{"name":125,"role":99,"phone":16,"phoneExt":16,"email":16},"Bernd Hartmann, MD",{"facility":127,"status":112,"city":128,"state":16,"zip":129,"country":115,"countryCode":116,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"KH der Barmherzigen Brüder, Innere Medizin I","Graz","8020",{"type":118,"coordinates":131},[132,133],15.44197,47.06733,{"lat":133,"lon":132},[136],{"name":137,"role":99,"phone":16,"phoneExt":16,"email":16},"Andrea Hammerl-Steiner, MD",{"facility":139,"status":140,"city":128,"state":16,"zip":141,"country":115,"countryCode":116,"cosmosGeoPoint":142,"geoPoint":144,"contacts":145},"Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Hämatologie","NOT_YET_RECRUITING","8036",{"type":118,"coordinates":143},[132,133],{"lat":133,"lon":132},[146],{"name":147,"role":99,"phone":16,"phoneExt":16,"email":16},"Armin Zebisch, MD",{"facility":149,"status":112,"city":150,"state":16,"zip":151,"country":115,"countryCode":116,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Universitätsklinik Innsbruck, Univ.-Klinik für Innere Medizin V, Hämatologie und Onkologie","Innsbruck","6020",{"type":118,"coordinates":153},[154,155],11.39454,47.26266,{"lat":155,"lon":154},[158],{"name":159,"role":99,"phone":16,"phoneExt":16,"email":16},"Dominik Wolf, MD",{"facility":161,"status":112,"city":162,"state":16,"zip":163,"country":115,"countryCode":116,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Universitätsklinikum Krems, Innere Medizin II Hämato-Onkologie","Krems","3500",{"type":118,"coordinates":165},[166,167],15.61415,48.40921,{"lat":167,"lon":166},[170],{"name":171,"role":99,"phone":16,"phoneExt":16,"email":16},"Martin Pecherstorfer, MD",{"facility":173,"status":112,"city":174,"state":16,"zip":175,"country":115,"countryCode":116,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"LKH Hochsteiermark, Abteilung für Hämato-Onkologie","Leoben","8700",{"type":118,"coordinates":177},[178,179],15.09144,47.3765,{"lat":179,"lon":178},[182],{"name":183,"role":99,"phone":16,"phoneExt":16,"email":16},"Angelika Pichler, MD",{"facility":185,"status":112,"city":186,"state":16,"zip":187,"country":115,"countryCode":116,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Ordensklinikum Linz GmbH, Barmherzige Schwestern, Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie","Linz","4010",{"type":118,"coordinates":189},[190,191],14.28611,48.30639,{"lat":191,"lon":190},[194],{"name":195,"role":99,"phone":16,"phoneExt":16,"email":16},"Gregor Aschauer, MD",{"facility":197,"status":112,"city":186,"state":16,"zip":198,"country":115,"countryCode":116,"cosmosGeoPoint":199,"geoPoint":201,"contacts":202},"Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie","4020",{"type":118,"coordinates":200},[190,191],{"lat":191,"lon":190},[203],{"name":204,"role":99,"phone":16,"phoneExt":16,"email":16},"Sigrid Machherndl-Spandl, MD",{"facility":206,"status":112,"city":186,"state":16,"zip":207,"country":115,"countryCode":116,"cosmosGeoPoint":208,"geoPoint":210,"contacts":211},"Kepler Universitätsklinikum Linz, Med. Campus III., Univ.-Klinik für Hämatologie und Internistische Onkologie","4021",{"type":118,"coordinates":209},[190,191],{"lat":191,"lon":190},[212],{"name":213,"role":99,"phone":16,"phoneExt":16,"email":16},"Clemens Schmitt, MD",{"facility":215,"status":112,"city":216,"state":16,"zip":217,"country":115,"countryCode":116,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Universitätsklinik für Innere Med. III, PMU Salzburg","Salzburg","5020",{"type":118,"coordinates":219},[220,221],13.04399,47.79941,{"lat":221,"lon":220},[224],{"name":97,"role":99,"phone":16,"phoneExt":16,"email":16},{"facility":226,"status":112,"city":227,"state":16,"zip":228,"country":115,"countryCode":116,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Universitätsklinikum St. Pölten, Klinische Abteilung für Innere Medizin 1","Sankt Pölten","3100",{"type":118,"coordinates":230},[231,232],15.63725,48.20762,{"lat":232,"lon":231},[235],{"name":236,"role":99,"phone":16,"phoneExt":16,"email":16},"Petra Pichler, MD",{"facility":238,"status":112,"city":239,"state":16,"zip":240,"country":115,"countryCode":116,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Klinikum Steyr, Innere Medizin II","Steyr","4400",{"type":118,"coordinates":242},[243,244],14.42127,48.04274,{"lat":244,"lon":243},[247],{"name":248,"role":99,"phone":16,"phoneExt":16,"email":16},"Johannes Andel, MD",{"facility":250,"status":112,"city":251,"state":16,"zip":252,"country":115,"countryCode":116,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Hanusch KH, 3. Med. Abteilung","Vienna","1140",{"type":118,"coordinates":254},[255,256],16.37208,48.20849,{"lat":256,"lon":255},[259],{"name":260,"role":99,"phone":16,"phoneExt":16,"email":16},"Felix Keil, MD",{"facility":262,"status":112,"city":251,"state":16,"zip":263,"country":115,"countryCode":116,"cosmosGeoPoint":264,"geoPoint":266,"contacts":267},"Klinik Ottakring, 1. Med. Abteilung","1160",{"type":118,"coordinates":265},[255,256],{"lat":256,"lon":255},[268],{"name":269,"role":99,"phone":16,"phoneExt":16,"email":16},"Martin Schreder, MD",{"facility":271,"status":112,"city":251,"state":16,"zip":272,"country":115,"countryCode":116,"cosmosGeoPoint":273,"geoPoint":275,"contacts":276},"Klinik Donaustadt: 2. Medizinische Abteilung","1220",{"type":118,"coordinates":274},[255,256],{"lat":256,"lon":255},[277],{"name":278,"role":99,"phone":16,"phoneExt":16,"email":16},"Margarete Stampfl-Mattersberger, MD",{"facility":280,"status":112,"city":281,"state":16,"zip":282,"country":115,"countryCode":116,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV","Wels","4600",{"type":118,"coordinates":284},[285,286],14.03333,48.16667,{"lat":286,"lon":285},[289],{"name":290,"role":99,"phone":16,"phoneExt":16,"email":16},"Sonja Heibl, MD",{"type":292,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100396191",false,"NCT04438889","Austrian Myeloid Registry","aMYELOIDr","Inclusion Criteria:\n\n* Age \\>17 years\n* Diagnosis of myeloid disease according to WHO 2016\n* Signed patient informed consent (IC)\n\nExclusion Criteria:\n\n* Patient is unable or unwilling to sign IC","ALL","18 Years",{"count":302,"type":303},3000,"ESTIMATED","10 Years","OBSERVATIONAL","The Austrian Myeloid Registry (aMYELOIDr) is a non-interventional study. It collects data from patients with the myeloid diseases, primarily myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML).The aMYELOIDr is multi-center database collecting data at various sites in Austria and potentially also at other centers in other countries in future. The registry has an electronic case report form (eCRF), where all data is entered by clinical trial personnel and\u002For physicians. It is set up to collect real-world experience in the management of patients with these diseases in Austria.",[308],"Myeloid Diseases",[75,79,70,83,296],"2025-04-09",{"date":312,"type":313},"2025-04-10","ACTUAL",{"date":315,"type":313},"2020-07-13",{"date":317,"type":303},"2030-04",{"name":5,"class":6},16]