Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-01-12 @ 1:47 PM
Study NCT ID:
NCT02675920
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2016-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of HCC High Risk Group Using Two Surveillance Tools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2016-02-04', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'radiation dose per patient', 'timeFrame': '12 months', 'description': 'from the 1st LDCT/US screening to last LDCT/US screening'}], 'primaryOutcomes': [{'measure': 'Detection rate of patients with HCC', 'timeFrame': '18 months', 'description': 'from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening'}], 'secondaryOutcomes': [{'measure': 'Detection rate of patients with early HCC', 'timeFrame': '18 months', 'description': 'from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening'}, {'measure': 'False referral rate', 'timeFrame': '18 months', 'description': 'from the 1st LDCT/US screening to six months follow-up after last (12 month after 1st LDCT/US) LDCT/US screening'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['surveillance', 'ultrasonography', 'computed tomography'], 'conditions': ['HCC']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk of HCC.', 'detailedDescription': 'Patients at high risk of HCC are recommended to undergo biannual surveillance using ultrasound. In this study, LDCT is performed in addition to biannual ultrasound surveillance in eligible patients to compare their sensitivity for HCC. Standard of reference would be follow-up imaging and/or gadoxetic acid-enhanced liver MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at high risk of HCC AND High Risk Index (\\>=2.33)\n\nRisk Index = 1.65 (if the prothrombin activity is \\<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \\<=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus \\[HCV\\] or hepatitis B surface antigen \\[HBsAg\\] is positive).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll conditions have to be satisfied to be enrolled.\n\n* \\> 20 years\n* high risk group of HCC according to AASLD guideline\n* risk index \\> = 2.33\n* currently on regular biannual surveillance using ultrasonography\n* sign informed consent\n\nExclusion Criteria:\n\nPatients with any of following condition cannot be enrolled.\n\n* previously diagnosed with HCC\n* any contraindication of contrast enhanced CT including allergic reaction to iodine\n* history of other malignancy'}, 'identificationModule': {'nctId': 'NCT02675920', 'briefTitle': 'A Study of HCC High Risk Group Using Two Surveillance Tools', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Prospective Cohort Study to Compare Contrast Enhanced Liver CT and Ultrasonography for Hepatocellular Carcinoma Surveillance in High-risk Group of HCC: Preliminary Study', 'orgStudyIdInfo': {'id': 'SNUH-2013-2284'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High risk group of HCC', 'description': 'known high risk group of HCC according to AASLD guideline. And patients whose risk index is equal to or higher than 2.33.\n\nRisk Index = 1.65 (if the prothrombin activity is \\<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \\<=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus \\[HCV\\] or hepatitis B surface antigen \\[HBsAg\\] is positive).\n\nPatients undergo ultrasonography and LDCT using non-ionic monomer iodinated CT contrast media biannually and the interval between ultrasound and LDCT is within 30 days.', 'interventionNames': ['Drug: non-ionic monomer iodinated CT contrast media']}], 'interventions': [{'name': 'non-ionic monomer iodinated CT contrast media', 'type': 'DRUG', 'otherNames': ['contrast enhanced CT'], 'description': 'patients underwent contrast-enhanced CT using aforementioned CT contrast media (non-ionic monomer iodinated CT contrast media)', 'armGroupLabels': ['High risk group of HCC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jeong Min Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taejoon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Reyon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong Min Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}