Nctid:
NCT06233929
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D001168", "term"=>"Arthritis"}, {"id"=>"D001172", "term"=>"Arthritis, Rheumatoid"}], "ancestors"=>[{"id"=>"D007592", "term"=>"Joint Diseases"}, {"id"=>"D009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D012216", "term"=>"Rheumatic Diseases"}, {"id"=>"D003240", "term"=>"Connective Tissue Diseases"}, {"id"=>"D001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M4476", "name"=>"Arthritis", "asFound"=>"Arthritis", "relevance"=>"HIGH"}, {"id"=>"M4480", "name"=>"Arthritis, Rheumatoid", "asFound"=>"Rheumatoid Arthritis", "relevance"=>"HIGH"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>2000}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-03-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2033-03-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2033-03-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Myopenia", "timeFrame"=>"10 years", "description"=>"Myopenia was defined by an ASMI≤ 7.0 kg/m2 in men and≤ 5.7 kg/m2 in women according to the Asian Working Group for Sarcopenia (AWGS)"}, {"measure"=>"CVDs", "timeFrame"=>"10 years", "description"=>"CVDs were defined as a verified medical history of angina pectoris, myocardial infarction, heart failure, ischemic or hemorrhagic stroke, and peripheral arterial disease \\[17\\], which was verified through a questionnaire survey and confirmation by medical record"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Rheumatoid Arthritis"]}, "descriptionModule"=>{"briefSummary"=>"An ongoing long-term cohort study is conducted in the Sun Yat-sen Memorial Hospital of Sun Yat-sen University, that is dedicated to recruiting RA patients, to identify the development of clinical, neuroimaging, and biochemical biomarkers for the diagnosis and prognosis of RA, especially for those with sarcopenia/myopenia\n\nTo improve the prognosis of RA, this study includes the following objectives:\n\n1. Construct a useful database to explore the secular dynamic progress of RA, especially the difference between early and lately RA, as well as to improve our understanding of the life-course factors affecting the process that will facilitate future research activities.\n2. Identify the potential markers (clinical, biomedical and imaging) affecting/predicting the development process of sarcopenia/myopenia or other prognosis in RA patients.\n3. Develop the related multi-modal prediction models with clinical, biomedical and imaging variables to improve the diagnosis and prognosis of RA."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients aged 18 years or older and diagnosed with RA according to 1987 ACR or 2010 ACR / EULAR classification criteria will be consecutively recruited during 2023 and 2033 from the Department of Rheumatology, SunYat-sen Memorial Hospital (SYSMH), Sun Yat-sen University in Guangzhou, and Department of Rheumatology, ShenShan Medical center, Memorial Hospital of Sun Yat-sen University in ShanWei, China. The exclusion criteria are as follows: 1) diagnosis with tumors without control, or AIDS; 2) serious disease in cardiovascular, kidney and blood and endocrine system; and 3) history of schizophrenia or epilepsy", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients aged 18 years or older and diagnosed with RA according to 1987 ACR or 2010 ACR / EULAR classification criteria\n\nExclusion Criteria:\n\n* Patients diagnosis with tumors without control, or AIDS\n* Patients with serious disease in cardiovascular, kidney and blood and endocrine system; and 3) history of schizophrenia or epilepsy"}, "identificationModule"=>{"nctId"=>"NCT06233929", "briefTitle"=>"Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA)", "organization"=>{"class"=>"OTHER", "fullName"=>"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"}, "officialTitle"=>"Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA)", "orgStudyIdInfo"=>{"id"=>"SYSKY-2023-1235-01"}}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
