Nctid:
NCT06227195
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010003", "term"=>"Osteoarthritis"}], "ancestors"=>[{"id"=>"D000001168", "term"=>"Arthritis"}, {"id"=>"D000007592", "term"=>"Joint Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000012216", "term"=>"Rheumatic Diseases"}], "browseLeaves"=>[{"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M12926", "name"=>"Osteoarthritis", "asFound"=>"Osteoarthritis", "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"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>40}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2019-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2021-12-31", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-18", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2021-12-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of Breg", "timeFrame"=>"4 and 8 weeks after DMM", "description"=>"Regulatory B cells"}], "secondaryOutcomes"=>[{"measure"=>"Cytokine secretion by T cells", "timeFrame"=>"4 and 8 weeks after DMM", "description"=>"Regulatory T cells"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Osteoarthritis", "Knee Arthritis"]}, "descriptionModule"=>{"briefSummary"=>"Our previous work has shown that Treg function is impaired in OA patients, but the cause of Treg deficiency has not been investigated. Since Breg has been shown to promote Treg differentiation and tissue repair, it is highly likely that the absence of the immunomodulatory effect of Breg in OA patients leads to impaired Treg differentiation. Based on the above data, we hypothesized that Breg plays a protective role in the course of OA by regulating T cell composition and promoting Treg differentiation through the secretion of anti-inflammatory factor IL-10"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"40 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with knee osteoarthritis come to our hospital", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:Patients who met the American College of Rheumatology diagnostic criteria for OA\n\n-\n\nExclusion Criteria:\n\n* Patients with trauma, other forms of arthritis such as rheumatoid arthritis, psoriatic arthritis or spondyloarthritis, and other active inflammatory diseases"}, "identificationModule"=>{"nctId"=>"NCT06227195", "briefTitle"=>"Mechanism of IL-10 Pathway-mediated Regulatory B Cell Dysfunction in Osteoarthritis", "organization"=>{"class"=>"OTHER", "fullName"=>"Qianfoshan Hospital"}, "officialTitle"=>"Mechanism of IL-10 Pathway-mediated Regulatory B Cell Dysfunction in Osteoarthritis", "orgStudyIdInfo"=>{"id"=>"2018S0097"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"250014", "city"=>"Jinan", "state"=>"Shandong", "country"=>"China", "facility"=>"The First Affiliated Hospital of Shandong First Medical University", "geoPoint"=>{"lat"=>36.66833, "lon"=>116.99722}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shufeng Li", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Chief Physician", "investigatorFullName"=>"Shufeng Li", "investigatorAffiliation"=>"Qianfoshan Hospital"}}}}
