[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576062":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":16,"centralContacts":20,"locations":25,"responsibleParty":53,"collaborators":7,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":7,"enrollmentInfo":65,"targetDuration":7,"studyType":68,"phases":7,"briefSummary":69,"conditions":70,"keywords":7,"overallStatus":74,"whyStopped":7,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",null,[9,13],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","Joint ultrasonography","Patients will undergo rheumatologic visits at baseline and scheduled follow-ups.\n\nRheumatologic visit procedures:\n\n* collection of patients' anamnesis of rheumatologic diaseases.\n* identification of painful and\u002For swollen joints and enthesis.\n* evaluation of joint and enthesis pain.\n* joint ultrasonography and assessment of joint structures and enthesis.",{"type":6,"name":14,"description":15,"armGroupLabels":7,"otherNames":7},"European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0","Patients will undergo dermatologic visits at baseline and scheduled follow-ups.\n\nDermatologic visit procedures:\n\n* collection of patients' oncologic anamnesis and general personal and lifestyle information.\n* administration of the quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) to assess the impact of rheumatologic adverse events on patients' quality of life.",[17],{"name":18,"affiliation":5,"role":19},"Ketty Peris, Prof","PRINCIPAL_INVESTIGATOR",[21],{"name":18,"role":22,"phone":23,"phoneExt":7,"email":24},"CONTACT","+390630154211","ketty.peris@policlinicogemelli.it",[26],{"facility":27,"status":7,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia","Rome","Lazio","00168","Italy","IT",{"type":34,"coordinates":35},"Point",[36,37],12.51133,41.89193,{"lat":37,"lon":36},[40,41,44,46,49,51],{"name":18,"role":22,"phone":23,"phoneExt":7,"email":24},{"name":42,"role":22,"phone":7,"phoneExt":7,"email":43},"Maria Mannino, MD","mariamannino04@yahoo.it",{"name":45,"role":19,"phone":7,"phoneExt":7,"email":7},"Ketty Peris",{"name":47,"role":48,"phone":7,"phoneExt":7,"email":7},"Alessandro Di Stefani","SUB_INVESTIGATOR",{"name":50,"role":48,"phone":7,"phoneExt":7,"email":7},"Maria Mannino",{"name":52,"role":48,"phone":7,"phoneExt":7,"email":7},"Laura Quattrini",{"type":54,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100576062","clinical-and-ultrasound-incidence-of-rheumatologic-immune-related-adverse-events-in-stage-iib-iv-melanoma-patients-100576062",false,"NCT06780397","Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients","Monocentric Study on the Clinical and Ultrasound Incidence of Rheumathologic Immune Related Adverse Events in Patients Affected by Stage IIB, IIC, III and IV Melanoma Under Therapy With Immune-checkpoint Inhibitors","Mel-Immuno-Reu","Inclusion Criteria:\n\n* Adult patients affected by stage IIB, IIC, III and IV melanoma who start systemic therapy with immune-checkpoint inhibitors.\n* Signature of the patient consent to the study.\n\nExclusion Criteria:\n\n* Patients aged below 18 years of age.\n* Patients who are unable to express consent to the study.\n* Patients with a diagnosis of chronic joint diseases: inflammatory arthritis, arthrosis, microcrystalline arthritis, septic arthritis etc.\n* Systemic diseases with likely joint involvement (inflammatory bowel disease, etc.)\n* Previous treatments with immune-checkpoint inhibitors or previous adjuvant therapy with immune-checkpoint inhibitors.","ALL","18 Years",{"count":66,"type":67},100,"ESTIMATED","OBSERVATIONAL","Rheumatologic adverse events are expected to affect between 3% and 7.5% of patients undergoing immunotherapy and are likely to be underdiagnosed.\n\nThe main aim of this observational prospective study is to investigate the clinical and ultrasonographic incidence of rheumathologic immune related adverse events in a cohort of patients affected by stage IIB, IIC, III and IV melanoma undergoing treatment with immune-checkpoint inhibitors.\n\nPatients will:\n\n* receive immune-checkpoint inhibitor therapy, according to disease stage and current National Guidelines.\n* undergo dermatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.\n* undergo rheumatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.\n* receive a quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.",[71,72,73],"Melanoma, Stage II","Melanoma Stage III","Melanoma Stage IV","NOT_YET_RECRUITING","2025-01-13",{"date":77,"type":78},"2025-01-17","ACTUAL",{"date":80,"type":67},"2025-02-01",{"date":82,"type":67},"2028-02-01",{"name":5,"class":6},1]