Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01943318
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2013-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Boramae Hospital Liver Cirrhosis Patient Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'At enrollement, 20 ml of blood will be collected for freezing and storage of serum and plasma, and constitution of a DNA library'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2013-08-22', 'studyFirstSubmitQcDate': '2013-09-11', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver-related outcome: Decompensated liver cirrhosis (ascites, variceal bleeding, hepatic encepahlopathy), occurence of hepatocellular carcinoma', 'timeFrame': '5 years', 'description': 'Cumulative incidence within 5 years Laboratory Tests: Albumin, Total bilirubin, prothrombin time, Platelet Hepatic venous pressure gradient measurement Imaging study like Liver CT or Liver ultrasonography Endoscopy for varix evaluation'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '5 years', 'description': 'overall mortality - whatever the cause of death'}, {'measure': 'Liver-related mortality', 'timeFrame': '5 years', 'description': 'cumulative incidence of liver-related deaths'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Liver Cirrhosis', 'Hepatocellular carcinoma'], 'conditions': ['Liver Cirrhosis', 'Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '22428859', 'type': 'BACKGROUND', 'citation': 'Dam Fialla A, Schaffalitzky de Muckadell OB, Touborg Lassen A. Incidence, etiology and mortality of cirrhosis: a population-based cohort study. Scand J Gastroenterol. 2012 Jun;47(6):702-9. doi: 10.3109/00365521.2012.661759. Epub 2012 Mar 19.'}, {'pmid': '22170417', 'type': 'BACKGROUND', 'citation': 'Reiberger T, Ferlitsch A, Payer BA, Pinter M, Homoncik M, Peck-Radosavljevic M; Vienna Hepatic Hemodynamic Lab. Non-selective beta-blockers improve the correlation of liver stiffness and portal pressure in advanced cirrhosis. J Gastroenterol. 2012 May;47(5):561-8. doi: 10.1007/s00535-011-0517-4. Epub 2011 Dec 15.'}, {'pmid': '31858403', 'type': 'DERIVED', 'citation': 'Cho Y, Choi YI, Oh S, Han J, Joo SK, Lee DH, Jung YJ, Kim BG, Lee KL, Kim W. Point shear wave elastography predicts fibrosis severity and steatohepatitis in alcohol-related liver disease. Hepatol Int. 2020 Mar;14(2):270-280. doi: 10.1007/s12072-019-10009-w. Epub 2019 Dec 19.'}, {'pmid': '30389550', 'type': 'DERIVED', 'citation': 'Kim HY, So YH, Kim W, Ahn DW, Jung YJ, Woo H, Kim D, Kim MY, Baik SK. Non-invasive response prediction in prophylactic carvedilol therapy for cirrhotic patients with esophageal varices. J Hepatol. 2019 Mar;70(3):412-422. doi: 10.1016/j.jhep.2018.10.018. Epub 2018 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'Liver cirrhosis represents a worldwide health problem and is a major cause of mortality. Cirrhosis is the common end for chronic alcohol abuse and hepatitis C and B virus infections. Patients who have cirrhosis have varying degrees of compensated liver function, and clinicians need to differentiate between those who have stable, compensated cirrhosis and those who have decompensated cirrhosis. It is shown various complications: portal hypertension, hepatocellular carcinoma, hepato-renal syndrome, etc.\n\nThus, it is important to have this information to manage disease and determine specific therapy. However, register-based studies in have not been reported in Korea.\n\nThe goal of this study is to describe the natural history of a large number of patients with liver cirrhosis prospectively followed, and to identify predictors of the occurrence of Hepatocellular carcinoma.', 'detailedDescription': 'The investigators are planning to recruit patients with liver cirrhosis, and collect the baseline clinical laboratory data. Biological tests, endoscopy,liver ultrasonography (including ARFI) and hepatic venous pressure gradient measurements will be performed if not done within 90 days prior to inclusion. During this visit, 20 ml of blood will be collected for freezing and storage of serum and plasma, and constitution of a DNA library.\n\nMonitoring: Patients will have regular surveillance with blood test, liver ultrasonography and medical consultation at least every 6 months, periodic assessment of esophageal, gastric varices and portal hypertensive gastropathy (every 1 year) and prevention of their rupture if any. An additional blood sampling of 20 ml will be taken at baseline and every year in order to perform whole blood, serum, plasma, peripheral blood mononuclear cells and DNA libraries; Data will be standardized and centralized in a single database.\n\nAnd alcoholic liver cirrhosis patients will undergo liver biopsy for polymerase chain reaction, western blot, immunohistochemistry and RNA analysis.\n\nAfter measurement of hepatic venous pressure gradient and liver stiffness at baseline a non-selective beta-blocker (NSBB,carvedilol) was initiated and increased stepwise (weekly) until the systolic blood pressure remained at\\>100 mmHg and the heart rate was not \\<60. The maximum target dose for carvedilol 25 mg/day. The hepatic venous pressure gradient response to NSBB was again assessed 6 weeks after the intake of carvedilol. A hemodynamic response to NSBB treatment was defined as a reduction in hepatic venous pressure gradient \\>=20% compared to baseline or to an absolute value \\<=12 mmHg. Compliance with therapy was monitored by monitoring of heart rate and blood pressure during clinical visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Seoul National University Boramae hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥19years old Proven cirrhosis\n* No previous hepatocellular carcinoma (treated or not)\n* Signed informed consent\n\nExclusion Criteria:\n\n* serious associated short-term life threatening disease (except associated HIV viral infection and the liver disease itself)\n* liver focal lesion suggestive of hepatocellular carcinoma\n* patient under guardianship\n* pregnant women\n* inability to regular monitoring, for whatever reason'}, 'identificationModule': {'nctId': 'NCT01943318', 'briefTitle': 'Boramae Hospital Liver Cirrhosis Patient Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Boramae Hospital'}, 'officialTitle': 'Prospective Cohort Study to Evaluate Long-term Outcomes in Patients With Liver Cirrhosis of Boramae Hospital', 'orgStudyIdInfo': {'id': 'BRM_LC_Cohort'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alcohol', 'description': 'Alcoholic Liver Cirrhosis\n\nParticipants will undergo liver biopsy. Participants will undergo hepatic venous pressure gradient measurement.', 'interventionNames': ['Procedure: Liver biopsy', 'Device: Hepatic venous pressure gradient (HVPG) measurement']}, {'label': 'Hepatitis B virus', 'description': 'Hepatitis B virus (HBV) Liver Cirrhosis', 'interventionNames': ['Procedure: Liver biopsy', 'Device: Hepatic venous pressure gradient (HVPG) measurement']}, {'label': 'Hepatitis C virus', 'description': 'Hepatitis C virus (HCV) Liver Cirrhosis', 'interventionNames': ['Procedure: Liver biopsy', 'Device: Hepatic venous pressure gradient (HVPG) measurement']}, {'label': 'Autoimmune', 'description': 'Autoimmune Cirrhosis', 'interventionNames': ['Procedure: Liver biopsy', 'Device: Hepatic venous pressure gradient (HVPG) measurement']}, {'label': 'Biliary', 'description': 'Primary or secondary biliary cirrhosis', 'interventionNames': ['Procedure: Liver biopsy', 'Device: Hepatic venous pressure gradient (HVPG) measurement']}, {'label': 'Toxic', 'description': 'Medication related cirrhosis', 'interventionNames': ['Procedure: Liver biopsy', 'Device: Hepatic venous pressure gradient (HVPG) measurement']}, {'label': 'Others', 'description': 'Hepatic venous pressure gradient (HVPG) measurement', 'interventionNames': ['Procedure: Liver biopsy', 'Device: Hepatic venous pressure gradient (HVPG) measurement']}], 'interventions': [{'name': 'Liver biopsy', 'type': 'PROCEDURE', 'description': 'Histologic evaluation', 'armGroupLabels': ['Alcohol', 'Autoimmune', 'Biliary', 'Hepatitis B virus', 'Hepatitis C virus', 'Others', 'Toxic']}, {'name': 'Hepatic venous pressure gradient (HVPG) measurement', 'type': 'DEVICE', 'description': 'Hepatic venous pressure gradient (HVPG) measurement', 'armGroupLabels': ['Alcohol', 'Autoimmune', 'Biliary', 'Hepatitis B virus', 'Hepatitis C virus', 'Others', 'Toxic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'SNU-SMG Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boramae Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Boramae Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Won Kim', 'investigatorAffiliation': 'Seoul National University Boramae Hospital'}}}}