[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407625":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":27,"overallOfficials":13,"centralContacts":32,"locations":42,"responsibleParty":123,"collaborators":13,"id":125,"slug":13,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":13,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":13,"enrollmentInfo":133,"targetDuration":13,"studyType":136,"phases":137,"briefSummary":138,"conditions":139,"keywords":13,"overallStatus":45,"whyStopped":13,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Gruppo Italiano Malattie EMatologiche dell'Adulto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"CD34+ blast cells modifications","Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.","at 24 months",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","This is a biological study for adult MDS patients who undergo HSCT procedure.The research is focused on the study of biological mechanisms of disease relapse after HSCT in MDS to provide the rationale to develop pre-emptive strategies in patients with high risk of transplant failure.\n\nViable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence.\n\nCD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant by using Single-cell sequencing.\n\nTo study genomic and transcriptomic changes in CD34+ blast cells at disease relapse after HSCT will be used TARGET-seq in parallel with unbiased whole-transcriptome analysis.",[22],{"label":23,"type":6,"description":24,"interventionNames":25},"Biological evaluation","evaluation of molecular changes in CD34+ blast cells at the time of relapse after allo-HSCT.",[26],"Other: bone marrow withdrawal",[28],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":13},"bone marrow withdrawal","bone marrow samples evaluation",[23],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":13,"email":37},"Paola Fazi","CONTACT","0670390528","p.fazi@gimema.it",{"name":39,"role":35,"phone":40,"phoneExt":13,"email":41},"Enrico Crea","0670390514","e.crea@gimema.it",[43,59,70,81,92,103,111],{"facility":44,"status":45,"city":46,"state":13,"zip":13,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto","RECRUITING","Bari","Italy","IT",{"type":50,"coordinates":51},"Point",[52,53],16.86982,41.12066,{"lat":53,"lon":52},[56],{"name":57,"role":35,"phone":13,"phoneExt":13,"email":58},"Pellegrino Musto","pellegrino.musto@uniba.it",{"facility":60,"status":45,"city":61,"state":13,"zip":13,"country":47,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Unità di Ricerca e di Malattie del sangue - Ematologia S. Luca Vecchio","Florence",{"type":50,"coordinates":63},[64,65],11.24626,43.77925,{"lat":65,"lon":64},[68],{"name":69,"role":35,"phone":13,"phoneExt":13,"email":13},"Valeria Santini",{"facility":71,"status":45,"city":72,"state":13,"zip":13,"country":47,"countryCode":48,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"AOU San Martino-IST-Ematologia 1","Genova",{"type":50,"coordinates":74},[75,76],11.87211,45.21604,{"lat":76,"lon":75},[79],{"name":80,"role":35,"phone":13,"phoneExt":13,"email":13},"Carmela Di Grazia",{"facility":82,"status":45,"city":83,"state":13,"zip":13,"country":47,"countryCode":48,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Sezione di Ematologia - Ospedale S.Maria della Misericordia","Perugia",{"type":50,"coordinates":85},[86,87],12.38878,43.1122,{"lat":87,"lon":86},[90],{"name":91,"role":35,"phone":13,"phoneExt":13,"email":13},"Cristina Mecucci",{"facility":93,"status":45,"city":94,"state":13,"zip":13,"country":47,"countryCode":48,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Dip. di Medicina Trasl. E di Precisione - U.O.C. Ematologia","Roma",{"type":50,"coordinates":96},[97,98],11.10642,44.99364,{"lat":98,"lon":97},[101],{"name":102,"role":35,"phone":13,"phoneExt":13,"email":13},"Massimo Breccia",{"facility":104,"status":45,"city":94,"state":13,"zip":13,"country":47,"countryCode":48,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Policlinico Tor Vergata",{"type":50,"coordinates":106},[97,98],{"lat":98,"lon":97},[109],{"name":110,"role":35,"phone":13,"phoneExt":13,"email":13},"Maria Teresa Voso",{"facility":112,"status":45,"city":113,"state":13,"zip":13,"country":47,"countryCode":48,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia","Rozzano",{"type":50,"coordinates":115},[116,117],9.1559,45.38193,{"lat":117,"lon":116},[120],{"name":121,"role":35,"phone":13,"phoneExt":13,"email":122},"Matteo E Della Porta","matteo.della_porta@hunimed.eu",{"type":124,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100407625",false,"NCT04587856","Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients","Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Diagnosis of MDS according to 2016 WHO criteria\n* Aged 18y or older\n* Patients who will receive allogeneic stem cell transplantation (HSCT)\n* Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws\n\nExclusion Criteria:\n\n* Second HSCT procedure.","ALL","18 Years",{"count":134,"type":135},38,"ESTIMATED","INTERVENTIONAL",[15],"This is a biological study for adult MDS patients who undergo HSCT procedure. Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence. CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant to study genomic and transcriptomic changes.",[140],"Myelodysplastic Syndromes","2024-10-21",{"date":143,"type":144},"2024-10-22","ACTUAL",{"date":146,"type":144},"2021-02-12",{"date":148,"type":135},"2025-03",{"name":5,"class":6},7]