Nctid:
NCT06233708
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002277", "term"=>"Carcinoma"}, {"id"=>"D006528", "term"=>"Carcinoma, Hepatocellular"}, {"id"=>"D012008", "term"=>"Recurrence"}], "ancestors"=>[{"id"=>"D009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D000230", "term"=>"Adenocarcinoma"}, {"id"=>"D008113", "term"=>"Liver Neoplasms"}, {"id"=>"D004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D008107", "term"=>"Liver Diseases"}, {"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "asFound"=>"Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M9613", "name"=>"Carcinoma, Hepatocellular", "asFound"=>"Hepatocellular Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M14850", "name"=>"Recurrence", "asFound"=>"Recurrence", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M11113", "name"=>"Liver Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M11107", "name"=>"Liver Diseases", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M3671", "name"=>"Adrenergic beta-Antagonists", "relevance"=>"LOW"}, {"id"=>"M14298", "name"=>"Propranolol", "relevance"=>"LOW"}, {"id"=>"M1718", "name"=>"Carvedilol", "relevance"=>"LOW"}, {"id"=>"M11110", "name"=>"Liver Extracts", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Arrhythmia Agents", "abbrev"=>"AnArAg"}, {"name"=>"Antihypertensive Agents", "abbrev"=>"AnAg"}, {"name"=>"Vasodilator Agents", "abbrev"=>"VaDiAg"}, {"name"=>"Channel Blockers", "abbrev"=>"ChanBlk"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>2092}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2008-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2022-05-31", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-28", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-28", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-05-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Kaplan-Meier survival analysis of HCC recurrence at 5-year follow-up", "timeFrame"=>"Baseline and 5-year follow-up", "description"=>"HCC recurrence, which was diagnosed based on pathological or radiographic evidence of new lesions consistent with HCC, and recurrence-free survival was collected and compared using Kaplan-Meier survival analysis."}, {"measure"=>"Multivariate Cox regression analysis of HCC recurrence at 5-year follow-up", "timeFrame"=>"Baseline and 5-year follow-up", "description"=>"Multivariate Cox regression analysis was performed to identify the risk factors for HCC recurrence."}], "secondaryOutcomes"=>[{"measure"=>"Kaplan-Meier survival analysis of overall survival at 5-year follow-up", "timeFrame"=>"Baseline and 5-year follow-up", "description"=>"Overall survival was collected and compared using Kaplan-Meier survival analysis."}, {"measure"=>"Multivariate Cox regression analysis of overall survival at 5-year follow-up", "timeFrame"=>"Baseline and 5-year follow-up", "description"=>"Multivariate Cox regression analysis was performed to identify the risk factors for overall mortality."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Hepatocellular Carcinoma Recurrent", "Hepatocellular Carcinoma"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to investigate the effect of non-selective beta-blocker (NSBB) on the recurrence of hepatocellular carcinoma (HCC) following liver transplantation in patients who underwent liver transplantation (LT) for treating hepatocellular carcinoma.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Is the usage of non-selective beta-blocker associated with decreased recurrence of hepatocellular carcinoma following liver transplantation?\n* Is the usage of non-selective beta-blocker associated with all-cause mortality following liver transplantation?\n\nResearchers will compare the NSBB group, including patients who received non-selective beta-blocker therapy for at least 30 consecutive days within 3 months prior to liver transplantation more than 30 days prior, with the control group to to see if non-selective beta-blocker treatment is associated with decreased recurrence of hepatocellular carcinoma following liver transplantation."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients who underwent liver transplantation at Asan Medical Center between Jan. 2008 - May 2022. Asan Medical Center is a tertiary, teaching hospital of the University of Ulsan College of Medicine, located in Seoul, South Korea.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adult patients\n* Underwent liver transplantation for treating hepatocellular carcinoma\n* Between Jan. 2008 - May. 2022\n\nExclusion Criteria:\n\n* Pediatric patients (Age under 18 years)\n* Re-transplantation\n* Multi-organ transplantation"}, "identificationModule"=>{"nctId"=>"NCT06233708", "briefTitle"=>"Association Between Pre-op Non-Selective Beta-Blockers and Hepatocellular Carcinoma Recurrence Post-Liver Transplant", "organization"=>{"class"=>"OTHER", "fullName"=>"Asan Medical Center"}, "officialTitle"=>"Association Between Pre-operative Use of Non-selective Beta-blockers With the Risk of Hepatocellular Carcinoma Recurrence Following Liver Transplantation : a Retrospective Cohort Study", "orgStudyIdInfo"=>{"id"=>"2023-0713"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"NSBB group", "description"=>"The NSBB group was defined as those who received NSBBs for at least 30 consecutive days within the 3 months prior to LT.", "interventionNames"=>["Drug: Non-Selective Beta-Adrenoreceptor Agonists for Systemic Use"]}, {"label"=>"Control group", "description"=>"Those who did not meet the above criteria were classified as the control group."}], "interventions"=>[{"name"=>"Non-Selective Beta-Adrenoreceptor Agonists for Systemic Use", "type"=>"DRUG", "description"=>"Non-selective blocker including Propranolol, Carvedilol PO was prescribed", "armGroupLabels"=>["NSBB group"]}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"Jun-Gol Song, MD, PhD", "role"=>"STUDY_CHAIR", "affiliation"=>"Department of Anesthesiology and Pain Medicine, Asan Medical Center"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Asan Medical Center", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Korea Health Industry Development Institute", "class"=>"OTHER_GOV"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Jun-Gol Song", "investigatorAffiliation"=>"Asan Medical Center"}}}}
