Nctid:
NCT06616103
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000006509", "term"=>"Hepatitis B"}, {"id"=>"D000019694", "term"=>"Hepatitis B, Chronic"}, {"id"=>"D000006505", "term"=>"Hepatitis"}, {"id"=>"D000006521", "term"=>"Hepatitis, Chronic"}, {"id"=>"D000005234", "term"=>"Fatty Liver"}, {"id"=>"D000008103", "term"=>"Liver Cirrhosis"}, {"id"=>"D000005355", "term"=>"Fibrosis"}], "ancestors"=>[{"id"=>"D000008107", "term"=>"Liver Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000006525", "term"=>"Hepatitis, Viral, Human"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000018347", "term"=>"Hepadnaviridae Infections"}, {"id"=>"D000004266", "term"=>"DNA Virus Infections"}, {"id"=>"D000002908", "term"=>"Chronic Disease"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}], "browseLeaves"=>[{"id"=>"M9595", "name"=>"Hepatitis B", "asFound"=>"Hepatitis B", "relevance"=>"HIGH"}, {"id"=>"M21609", "name"=>"Hepatitis B, Chronic", "asFound"=>"Chronic Hepatitis B", "relevance"=>"HIGH"}, {"id"=>"M8375", "name"=>"Fatty Liver", "asFound"=>"Steatosis", "relevance"=>"HIGH"}, {"id"=>"M8485", "name"=>"Fibrosis", "asFound"=>"Fibrosis", "relevance"=>"HIGH"}, {"id"=>"M11103", "name"=>"Liver Cirrhosis", "asFound"=>"Cirrhosis of Liver", "relevance"=>"HIGH"}, {"id"=>"M9592", "name"=>"Hepatitis A", "relevance"=>"LOW"}, {"id"=>"M9591", "name"=>"Hepatitis", "asFound"=>"Hepatitis", "relevance"=>"HIGH"}, {"id"=>"M9607", "name"=>"Hepatitis, Chronic", "asFound"=>"Chronic Hepatitis", "relevance"=>"HIGH"}, {"id"=>"M11107", "name"=>"Liver Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M9610", "name"=>"Hepatitis, Viral, Human", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M20487", "name"=>"Hepadnaviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T5868", "name"=>"Visceral Steatosis", "asFound"=>"Steatosis", "relevance"=>"HIGH"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>111}, "targetDuration"=>"1 Year", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-26", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-08-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-19", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-08-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"diagnostic performance of CT attenuatio parameters in assessing hepatic steatosis and fibrosis", "timeFrame"=>"At the time of enrollment", "description"=>"diagnostic performance of CT attenuatio parameters in assessing hepatic steatosis and fibrosis using MRI-PDFF and MR elastography as reference standards"}], "secondaryOutcomes"=>[{"measure"=>"Consistency between MRI-derived body composition data and CT-derived data", "timeFrame"=>"At the time of enrollment", "description"=>"Consistency between MRI-derived body composition data and CT-derived data using automated 3D organ segmentation algorithm"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Chronic Hepatitis B", "Steatosis of Liver", "Fibrosis and Cirrhosis of Liver"]}, "descriptionModule"=>{"briefSummary"=>"This study aims to evaluate diagnostic performance of CT attenuation parameters acquired using deep learning algorithm in assessing hepatic steatosis and fibrosis."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"19 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with chronic hepatitis B who follow up at Seoul National University Hospital having no history of hepatic malignancies", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* chronic hepatitis B\n* no chronic liver disease other than chronic hepatitis B\n* Body mass index \\>= 23\n\nExclusion Criteria:\n\n* pregnant women\n* unable to perform MRI examinations due to claustrophobia or metallic foreign body\n* suspicious hepatic malignancy on previous imaging studies\n* history of local treatment for hepatic lesions\n* history of surgery or catheter insertion of liver or spleen"}, "identificationModule"=>{"nctId"=>"NCT06616103", "briefTitle"=>"Quantitative CT Imaging Parameters for Assessing Hepatic Steatosis in CHB", "organization"=>{"class"=>"OTHER", "fullName"=>"Seoul National University Hospital"}, "officialTitle"=>"Utility of Quantitative Imaging Parameters from Deep Learning-based CT Segmentation in Assessing Hepatic Steatosis and Fibrosis in Chronic Hepatitis B: a Prospective Study Using MRI As the Reference Standard", "orgStudyIdInfo"=>{"id"=>"CHB prospective MEDIP"}, "secondaryIdInfos"=>[{"id"=>"RS-2023-00253896", "type"=>"OTHER_GRANT", "domain"=>"National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT)"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"computerized tomography", "type"=>"DIAGNOSTIC_TEST", "description"=>"noncontrast abdominal CT"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"03080", "city"=>"Seoul", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"Jeongin Yoo, M.D.", "role"=>"CONTACT", "email"=>"jeongin527@snu.ac.kr", "phone"=>"+82-220723107"}], "facility"=>"Seoul National University Hospital", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Seoul National University Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Clinical assistant professor", "investigatorFullName"=>"Jeongin Yoo", "investigatorAffiliation"=>"Seoul National University Hospital"}}}}
