Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-01 @ 10:47 AM
Study NCT ID:
NCT01360892
Status:
UNKNOWN
Last Update Posted:
2011-05-26
First Post:
2011-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D005355', 'term': 'Fibrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-24', 'studyFirstSubmitDate': '2011-05-21', 'studyFirstSubmitQcDate': '2011-05-24', 'lastUpdatePostDateStruct': {'date': '2011-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of carcinogenesis of hepatocellular carcinoma', 'timeFrame': 'every four or six months', 'description': 'Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais'}], 'secondaryOutcomes': [{'measure': 'Cancer-free survival', 'timeFrame': 'every four or six months', 'description': 'Cancer-free survival is defined as the time from registration to death due to cencer or any cause'}, {'measure': 'Overall survival', 'timeFrame': 'one year', 'description': 'Overall survival is defined as the time from registration to death due to any cause'}, {'measure': 'The cumulative incidence and severity of gastro-esophageal varices', 'timeFrame': 'one year', 'description': 'It is estimated by gastrointestinal scope for every year'}, {'measure': 'The cumulative incidence and severity of decompensated cirrhosis', 'timeFrame': 'one year', 'description': 'Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis B virus', 'Hepatitis C virus', 'Chronic hepatitis', 'Liver chlorosis', 'Liver stiffness', 'Liver fibrosis'], 'conditions': ['Chronic Hepatitis B', 'Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements will predict prospectively the incidence of hepatocellular carcinoma, the incidence and severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C patients.', 'detailedDescription': 'The aim of this study is to validate the predictive value of Real-time Tissue Elastography® by comparison with serum marker or FibroScan® in chronic hepatitis B or C patients.\n\nEvery year and for three years, we performed Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy. If in the hospital they can perform FibroScan®, FobroScan® also be performed.\n\nSubjects were also performed ultrasonography (US), computed sonography (CT) or magnetic resonance imaging (MRI) evry four or six months.\n\nThe time between the Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy and FiroScan® must not exceed four weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with chronic hepatitis B or C will be eligible for the study. Subjects with other infectious viral diseases or chronic liver disease are excluded for study enrollment.\n\nReal-time Tissue Elastography®, serum maker and gastrointestinal endoscopy are performed. If in the hopsital they can perform FibroScan®, FobroScan® also be performed.\n\nThe time between the Real-time Tissue Elastography®, blood sampling, FiroScan® must not exceed four weeks.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female and at least 20 years of age\n* Chronic hepatitis B or Chronic hepatitis C\n\nExclusion Criteria:\n\n* Evidence or history of hepatocellular carcinoma\n* History of alcohol abuse (alcohol intake \\> 20g/day)\n* Pregnant or lactating patients\n* Psychosis'}, 'identificationModule': {'nctId': 'NCT01360892', 'acronym': 'PICTURE', 'briefTitle': 'Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography', 'organization': {'class': 'OTHER', 'fullName': 'Kindai University'}, 'officialTitle': 'Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography', 'orgStudyIdInfo': {'id': 'JLOG1003'}}, 'contactsLocationsModule': {'locations': [{'zip': '589-8511', 'city': 'Ōsaka-sayama', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Norihisa Yada, M.D.', 'role': 'CONTACT', 'email': 'yada@med.kindai.ac.jp', 'phone': '+81-72-366-0221', 'phoneExt': '3525'}, {'name': 'Kazuomi Ueshima, M.D.', 'role': 'CONTACT', 'email': 'kaz-ues@med.kindi.ac.jp', 'phone': '+81-72-366-0221', 'phoneExt': '3525'}], 'facility': 'Kinki University Faculty of Medicine', 'geoPoint': {'lat': 34.49524, 'lon': 135.55069}}], 'centralContacts': [{'name': 'Norihisa Yada, M.D.', 'role': 'CONTACT', 'email': 'yada@med.kindai.ac.jp', 'phone': '+81-72-366-0221', 'phoneExt': '3525'}, {'name': 'Kazuomi Ueshima, M.D.', 'role': 'CONTACT', 'email': 'kaz-ues@med.kindi.ac.jp', 'phone': '+81-72-366-0221', 'phoneExt': '3525'}], 'overallOfficials': [{'name': 'Masatoshi Kudo, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Kinki University Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kindai University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Japan Liver Oncology Group Organization:', 'oldOrganization': 'Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine'}}}}