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Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution

Recruitingn/aAges 18 Years - anyAllAzienda USL Reggio Emilia - IRCCS
NCT07214324 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 tha

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age \>18 years * Male or female patients * Histologically confirmed diagnosis of MGUS, SMM, or MM according to ESMO 2021 guidelines * Willing and able to provide written informed consent HEALTHY VOLUNTEERS (HV) * Age \>60 years * Diagnosis of osteoarthritis (OA) * Scheduled for hospitalization for surgical treatment of OA (endoprosthesis or arthroplasty) * Willing and able to provide written informed consent Exclusion Criteria: * Patients: * Active current infection * Autoimmune disease * Women of childbearing potential unable to exclude pregnancy * Use of high-dose corticosteroids within the past 7 days, potentially affecting immunome composition Healthy Volunteers: * Prior joint surgery or severe joint deformity * Recent trauma, osteonecrosis, or OA caused by prior/current joint infection * Metabolic disorders * Previous or current cancer diagnosis * Autoimmune diseases (e.g., rheumatoid arthritis)
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What it tests

  • Collection of biological material
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Where

4 sites
Istituto Ortopedico Rizzoli IRCCS
Bologna, Italy
UO Ematologia Azienda Ospedaliero-Universitaria "Policlinico Rodolico San Marco"
Catania, Italy
UOC di Ematologia, Dipartimento di Oncologia, AOU Policlinico "Paolo Giaccone"
Palermo, Italy
S.C Ematologia - Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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