Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT01350167
Status:
UNKNOWN
Last Update Posted:
2011-05-24
First Post:
2011-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Screening for Liver Cancer With CT vs. Ultrasound in Patients With Advanced Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D058625', 'term': 'End Stage Liver Disease'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'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': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-23', 'studyFirstSubmitDate': '2011-05-03', 'studyFirstSubmitQcDate': '2011-05-06', 'lastUpdatePostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System)', 'timeFrame': '6-12 months', 'description': 'Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging according according to BCLC recommendations'}], 'secondaryOutcomes': [{'measure': 'Cost - Effectiveness of screening measure', 'timeFrame': '1 year', 'description': 'Cost of each screening protocol to identify one very early/early stage HCC'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'Liver Cancer', 'Ultrasound', 'Computed Tomography', 'Alpha fetoprotein', 'Cirrhosis', 'Screening', 'Advanced Liver Disease'], 'conditions': ['Cirrhosis', 'End Stage Liver Disease', 'Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '23750991', 'type': 'DERIVED', 'citation': 'Pocha C, Dieperink E, McMaken KA, Knott A, Thuras P, Ho SB. Surveillance for hepatocellular cancer with ultrasonography vs. computed tomography -- a randomised study. Aliment Pharmacol Ther. 2013 Aug;38(3):303-12. doi: 10.1111/apt.12370. Epub 2013 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ultrasound or CT scanning is more effective at detecting early liver cancer in patients with advanced liver disease.', 'detailedDescription': 'Most cases of hepatocellular carcinoma (HCC) arise in patients with advanced liver disease, usually cirrhosis. Most patients with clinically evident HCC are not candidates for treatment with curative intent because of large tumor size, invasion of hepatic or portal veins, or metastatic disease. For this reason, screening for HCC at an asymptomatic and potentially curable stage in patients with advanced liver disease has been recommended by some authorities. Screening with various methods, of which ultrasound (US) and alpha-fetoprotein (AFP) have been the most extensively studied, has become accepted practice. Recently the technique of imaging the liver with or during both the hepatic arterial and portal venous phases of intravenous contrast ("liver-shuttle") has shown increased sensitivity in detecting HCCs compared to US.\n\nThe hypothesis of this study is that CT using a "liver-shuttle" protocol once a year is more sensitive and specific than US twice a year, both in combination with AFP for identification of potentially curable HCC in patients with cirrhosis. Patients will be randomized to "routine," accepted screening with hepatic US and AFP testing every 6 months or AFP testing every 6 months wtih triphasic CT every 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* liver biopsy or clinical diagnosis compatible with advanced liver fibrosis or cirrhosis\n* potential candidate for treatment of HCC\n* imaging study involving the liver in the last 12 months without evidence for HCC\n* must be a veteran in VISN 23\n\nExclusion Criteria:\n\n* active or untreated malignancy other than non-melanoma skin cancer\n* patients with advanced medical conditions such as severe cardiovascular disease, COPD, or severe end-stage liver disease\n* patients unable to receive intravenous contrast due to advanced kidney disease or severe allergy\n* history of liver mass identified on imaging study'}, 'identificationModule': {'nctId': 'NCT01350167', 'briefTitle': 'Screening for Liver Cancer With CT vs. Ultrasound in Patients With Advanced Liver Disease', 'organization': {'class': 'FED', 'fullName': 'Minneapolis Veterans Affairs Medical Center'}, 'officialTitle': 'Screening for Hepatocellular Carcinoma With Triphasic Helical CT vs. US With Alpha-fetoprotein in Patients With Advanced Liver Disease', 'orgStudyIdInfo': {'id': '3034-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Triphasic CT', 'description': 'Triphasic CT of the abdomen with and without contrast every 12 months with alpha-fetoprotein every 6 months.', 'interventionNames': ['Procedure: Screening']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound', 'description': 'Ultrasound of the upper left quadrant with alpha-fetoprotein testing every 6 months.', 'interventionNames': ['Procedure: Screening']}], 'interventions': [{'name': 'Screening', 'type': 'PROCEDURE', 'description': 'Triphasic CT of the abdomen with and without contrast every 12 months and alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years.\n\nUltrasound of the upper left quadrant every 6 months with alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years.', 'armGroupLabels': ['Triphasic CT', 'Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Pocha, MD, PhD', 'role': 'CONTACT', 'email': 'christine.pocha@va.gov', 'phone': '612-467-4100'}, {'name': 'Kelly McMaken, MPH', 'role': 'CONTACT', 'email': 'kelly.mcmaken@va.gov', 'phone': '612-467-4149'}, {'name': 'Christine Pocha, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Minneapolis Veterans Affairs Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Christine Pocha, MD, PhD', 'role': 'CONTACT', 'email': 'christine.pocha@va.gov', 'phone': '612-467-4100'}, {'name': 'Kelly A McMaken, MPH', 'role': 'CONTACT', 'email': 'kelly.mcmaken@va.gov', 'phone': '612-467-4149'}], 'overallOfficials': [{'name': 'Christine Pocha, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis Veterans Affairs Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minneapolis Veterans Affairs Medical Center', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'Christine Pocha/Staff Physician', 'oldOrganization': 'Minneapolis VA Medical Center'}}}}