Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT05304234
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2022-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liver Cancer Disparities in American Indian and Alaska Native Persons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'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'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'we are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance with screening protocol', 'timeFrame': '12 months', 'description': 'Compliance with conducting all three screening tests'}, {'measure': 'Feasibility of screening protocol', 'timeFrame': '12 months', 'description': 'Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma', 'Cirrhosis, Liver', 'Hepatitis B']}, 'descriptionModule': {'briefSummary': 'We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.', 'detailedDescription': 'We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.\n\nWe will compare the aMRI vs. the US arm with respect to the following outcomes:\n\n1. Compliance/feasibility of conducting all three screening tests (0, 6 and 12 months) - Primary Outcome\n2. Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system - Primary Outcome\n3. Proportion diagnosed with HCC and stage at diagnosis - Secondary Outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhosis, any etiology, or chronic HBV infection\n* High risk of HCC\n* Age 18-75\n* Competent to provide informed consent\n\nExclusion Criteria:\n\n* Prior diagnosis of HCC\n* Current suspicion of HCC\n* Prior receipt of any organ transplantation\n* Participation in another HCC screening trial\n* CTP score \\>=10\n* MELD-Na score \\>20\n* GFR\\<30\n* Poor life expectancy (\\<5 years)\n* Contraindication to MRI\n* Inability to complete study visits\n* Currently pregnant'}, 'identificationModule': {'nctId': 'NCT05304234', 'briefTitle': 'Liver Cancer Disparities in American Indian and Alaska Native Persons', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Liver Cancer Disparities in American Indian and Alaska Native Persons', 'orgStudyIdInfo': {'id': 'STUDY00013583'}, 'secondaryIdInfos': [{'id': '1P20CA252732-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1P20CA252732-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound + AFP', 'description': 'Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months', 'interventionNames': ['Diagnostic Test: Ultrasound or abbreviated MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'aMRI + AFP', 'description': 'Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months', 'interventionNames': ['Diagnostic Test: Ultrasound or abbreviated MRI']}], 'interventions': [{'name': 'Ultrasound or abbreviated MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Abdominal ultrasound or abbreviated MRI', 'armGroupLabels': ['Ultrasound + AFP', 'aMRI + AFP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74464', 'city': 'Tahlequah', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jorge Mera', 'role': 'CONTACT'}, {'name': 'Whitney Essex', 'role': 'CONTACT'}], 'facility': 'Cherokee Nation Health Service', 'geoPoint': {'lat': 35.91537, 'lon': -94.96996}}], 'centralContacts': [{'name': 'Jennifer R Harry', 'role': 'CONTACT', 'email': 'jharry@medicine.washington.edu', 'phone': '206-616-0397'}, {'name': 'Stephanie Y Park', 'role': 'CONTACT', 'email': 'sypark22@uw.edu', 'phone': '206-744-7050'}], 'overallOfficials': [{'name': 'George Ioannou, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Cherokee Nation Health Services', 'class': 'UNKNOWN'}, {'name': 'Alaska Native Tribal Health Consortium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, School of Medicine, Gastroenterology', 'investigatorFullName': 'George Ioannou', 'investigatorAffiliation': 'University of Washington'}}}}