[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545533":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":18,"responsibleParty":92,"collaborators":10,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":108,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":10,"overallStatus":21,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Fondazione IRCCS Policlinico San Matteo di Pavia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with MGUS and aFLCR and with SMM",null,"Part A: Patients with MGUS and aFLCR and patients with SMM undergoing an active, biomarker-based screening of presymptomatic amyloid organ involvement.\n\nPart B: Newly diagnosed patients with AL amyloidosis identified through Part A or with clinically overt AL amyloidosis evaluated in the frame of routine clinical assessments and referred to the Amyloidosis Research and Treatment Center in Pavia or managed locally at the participating Italian Hematologic Departments",[13],"Other: no intervention",[15],{"type":6,"name":16,"description":16,"armGroupLabels":17,"otherNames":10},"no intervention",[9],[19,42,58,76],{"facility":20,"status":21,"city":22,"state":10,"zip":10,"country":23,"countryCode":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":31},"Azienda Ospedaliera Policlinico Consorziale","RECRUITING","Bari","Italy","IT",{"type":26,"coordinates":27},"Point",[28,29],16.86982,41.12066,{"lat":29,"lon":28},[32,37,39],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"PELLEGRINO MUSTO, MD","CONTACT","080 5593471","ematologiacontrapianto@policlinico.ba.it",{"name":33,"role":38,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":40,"role":41,"phone":10,"phoneExt":10,"email":10},"Angela Minervini, MD, PhD","SUB_INVESTIGATOR",{"facility":43,"status":21,"city":44,"state":10,"zip":10,"country":23,"countryCode":24,"cosmosGeoPoint":45,"geoPoint":49,"contacts":50},"Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco","Catania",{"type":26,"coordinates":46},[47,48],15.07041,37.49223,{"lat":48,"lon":47},[51,55,56],{"name":52,"role":34,"phone":53,"phoneExt":10,"email":54},"Francesco Di Raimondo, MD","095\u002F378.1956","segremat@unict.it",{"name":52,"role":38,"phone":10,"phoneExt":10,"email":10},{"name":57,"role":41,"phone":10,"phoneExt":10,"email":10},"Concetta Maria Sebastiana Conticello, MD, PhD",{"facility":59,"status":21,"city":60,"state":10,"zip":10,"country":23,"countryCode":24,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Fondazione Irccs Policlinico San Matteo","Pavia",{"type":26,"coordinates":62},[63,64],9.15917,45.19205,{"lat":64,"lon":63},[67,71,72,74],{"name":68,"role":34,"phone":69,"phoneExt":10,"email":70},"GIOVANNI PALLADINI, MD, PhD","+390382502994","segreteria.amiloidosi@smatteo.pv.it",{"name":68,"role":38,"phone":10,"phoneExt":10,"email":10},{"name":73,"role":38,"phone":10,"phoneExt":10,"email":10},"Luca Arcaini, MD",{"name":75,"role":41,"phone":10,"phoneExt":10,"email":10},"Mario Ulisse Nuvolone, MD, PhD",{"facility":77,"status":21,"city":78,"state":10,"zip":10,"country":23,"countryCode":24,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"EMATOLOGIA - Città della Scienza e Salute - Torino","Torino",{"type":26,"coordinates":80},[81,82],11.99138,44.88856,{"lat":82,"lon":81},[85,89,90],{"name":86,"role":34,"phone":87,"phoneExt":10,"email":88},"FRANCESCA MARIA GAY, MD, PhD","011.633.5550 - 5935","ematologia@cittadellasalute.to.it",{"name":86,"role":38,"phone":10,"phoneExt":10,"email":10},{"name":91,"role":41,"phone":10,"phoneExt":10,"email":10},"Stefania Oliva, MD, PhD",{"type":38,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Giovanni Palladini","MD, PhD","100545533","promoting-diagnosis-and-management-of-al-in-italy-prodigality-100545533",false,"NCT06383143","Promoting Diagnosis and Management of AL in Italy (ProDigALIty)","ProDigALIty","PART A\n\nInclusion Criteria:\n\n* diagnosis of MGUS with altered FLCR or SMM;\n* treatment-naïve;\n* age ≥18 years;\n* ability to understand and willingness to sign an informed consent;\n* planned follow-up at participating center.\n\nExclusion Criteria:\n\n* Diagnosis of symptomatic monoclonal gammopathies;\n* Previous treatment for monoclonal gammopathies.\n\nPART B\n\nInclusion criteria:\n\n* diagnosis of systemic AL amyloidosis;\n* treatment-naïve;\n* age ≥18 years;\n* ability to understand and willingness to sign an informed consent;\n* planned follow-up at participating center.\n\nExclusion criteria:\n\n* non-AL amyloidosis;\n* previous treatment for AL amyloidosis.","ALL","18 Years","99 Years",{"count":106,"type":107},760,"ESTIMATED","2 Years","OBSERVATIONAL","The investigators plan to establish a dedicated network of Italian Hematologic Departments interconnected with the Amyloidosis Research and Treatment Center in Pavia to:\n\n1. Implement a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis among at-risk patients, including patients with monoclonal gammopathy of undetermined significance, MGUS, and altered free light chain ratio (aFLCR), and patients with smoldering multiple myeloma (SMM)\n2. Expedite and facilitate patients' referral and their enrollment in ongoing pre-clinical\u002Fclinical studies, also to reflect a broader spectrum of the real-world population of patients with AL amyloidosis in Italy;\n3. Investigate the clinical utility of novel diagnostic technologies, including light chain sequencing and N-glycosylation analysis",[112,113,114],"AL Amyloidosis","Smoldering Multiple Myeloma","Monoclonal Gammopathy of Undetermined Significance","2026-04-13",{"date":117,"type":118},"2026-04-16","ACTUAL",{"date":120,"type":118},"2023-05-01",{"date":122,"type":107},"2026-05-01",{"name":5,"class":6},4]