[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609418":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":79,"collaborators":81,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":10,"enrollmentInfo":96,"targetDuration":10,"studyType":99,"phases":10,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MGUS, SMM and MM patients",null,"Patients with monoclonal gammopathy of undeterminated significance, smoldering multiple myeloma, or multiple myeloma",[13],"Other: Collection of biological material",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy volunteers","Patients with a clinical and radiological diagnosis of osteoarthritis who undergo endo or arthro-prosthesis surgery",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"OTHER","Collection of biological material","For MGUS, SMM and MM patients, biological material (bone marrow aspirate, bone marrow biopsy, peripheral blood) consists exclusively of left-over samples obtained during routine diagnostic procedures and clinical practice management of their disease.\n\nFor healthy volunteers, biological material includes waste bone tissue obtained during orthopedic surgery (endo- or arthro-prosthesis) and peripheral blood collected for research purposes.\n\nBoth cohort of patient will be asked to donate gingival crevicular fluid (GCF) (this is a non-invasive procedure with no associated risks).",[15,9],[25],{"name":26,"affiliation":27,"role":28},"Antonino Neri, MD, PhD","Azienda USL - IRCCS di Reggio Emilia","STUDY_CHAIR",[30],{"name":31,"role":32,"phone":10,"phoneExt":10,"email":33},"Noemi Puccio","CONTACT","noemi.puccio@ausl.re.it",[35,47,55,63],{"facility":36,"status":37,"city":38,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":10},"Istituto Ortopedico Rizzoli IRCCS","ACTIVE_NOT_RECRUITING","Bologna","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],11.33875,44.49381,{"lat":45,"lon":44},{"facility":48,"status":37,"city":49,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":50,"geoPoint":54,"contacts":10},"UO Ematologia Azienda Ospedaliero-Universitaria \"Policlinico Rodolico San Marco\"","Catania",{"type":42,"coordinates":51},[52,53],15.07041,37.49223,{"lat":53,"lon":52},{"facility":56,"status":37,"city":57,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":58,"geoPoint":62,"contacts":10},"UOC di Ematologia, Dipartimento di Oncologia, AOU Policlinico \"Paolo Giaccone\"","Palermo",{"type":42,"coordinates":59},[60,61],13.3636,38.1166,{"lat":61,"lon":60},{"facility":64,"status":65,"city":66,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"S.C Ematologia - Azienda USL IRCCS di Reggio Emilia","RECRUITING","Reggio Emilia",{"type":42,"coordinates":68},[69,70],10.63125,44.69825,{"lat":70,"lon":69},[73,76],{"name":74,"role":32,"phone":10,"phoneExt":10,"email":75},"Cecilia Fabiano","cecilia.fabiano@ausl.re.it",{"name":77,"role":32,"phone":10,"phoneExt":10,"email":78},"Barbara Gamberi, MD","barbara.gamberi@ausl.re.it",{"type":80,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[82,84],{"name":83,"class":20},"European Union",{"name":85,"class":20},"Ministero della Salute, Italy","100609418","integrative-multi-omics-analysis-to-predict-monoclonal-gammopathies-clinical-evolution-100609418",false,"NCT07214324","Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution","PNRR-2022-1237","Inclusion Criteria:\n\n* Age \\>18 years\n* Male or female patients\n* Histologically confirmed diagnosis of MGUS, SMM, or MM according to ESMO 2021 guidelines\n* Willing and able to provide written informed consent\n\nHEALTHY VOLUNTEERS (HV)\n\n* Age \\>60 years\n* Diagnosis of osteoarthritis (OA)\n* Scheduled for hospitalization for surgical treatment of OA (endoprosthesis or arthroplasty)\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Patients:\n\n  * Active current infection\n  * Autoimmune disease\n  * Women of childbearing potential unable to exclude pregnancy\n  * Use of high-dose corticosteroids within the past 7 days, potentially affecting immunome composition\n\nHealthy Volunteers:\n\n* Prior joint surgery or severe joint deformity\n* Recent trauma, osteonecrosis, or OA caused by prior\u002Fcurrent joint infection\n* Metabolic disorders\n* Previous or current cancer diagnosis\n* Autoimmune diseases (e.g., rheumatoid arthritis)",true,"ALL","18 Years",{"count":97,"type":98},60,"ESTIMATED","OBSERVATIONAL","This prospective, multicenter, observational study aims to identify molecular and immunological markers associated with disease progression in patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). By integrating genomic, transcriptomic, immunophenotypic, and oral microbiome analyses, the study seeks to characterize the biological mechanisms underlying the transition to symptomatic multiple myeloma (MM). The study also includes in vitro modeling to investigate bone damage and immune dysfunction. Healthy volunteers (HV) undergoing joint replacement surgery for osteoarthritis will serve as controls. The ultimate goal is to improve early risk stratification and support future preventive strategies through a multi-omics approach. There is a pressing need for new strategies to identify high-risk individuals based on biological rather than purely clinical parameters. This study proposes an integrative, multi-omics approach to investigate the transition from MGUS\u002FSMM to MM. By analyzing the immunome and oral microbiome alongside molecular profiling, the goal is to identify reliable biomarkers of progression. The resulting insights could be enable more accurate risk stratification and guide the design of future preventive clinical trials aimed at delaying or halting disease evolution.",[102,103,104],"Monoclonal Gammopathy of Undetermined Significance (MGUS)","Smoldering Multiple Myeloma (SMM)","Multiple Myeloma (MM)",[106,107,108,109,110],"plasma cells","multi-omics","biomarkers","bone marrow microenvironment","microbiome","2026-04-22",{"date":113,"type":114},"2026-04-23","ACTUAL",{"date":116,"type":114},"2025-03-17",{"date":118,"type":98},"2026-12-31",{"name":5,"class":6},4]