Liver Cancer Disparities in American Indian and Alaska Native Persons
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
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.
We will compare the aMRI vs. the US arm with respect to the following outcomes:
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Compliance/feasibility of conducting all three screening tests (0, 6 and 12 months) - Primary Outcome
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Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system - Primary Outcome
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Proportion diagnosed with HCC and stage at diagnosis - Secondary Outcome
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Ultrasound + AFP Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months |
Diagnostic Test: Ultrasound or abbreviated MRI
Abdominal ultrasound or abbreviated MRI
|
Active Comparator: aMRI + AFP Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months |
Diagnostic Test: Ultrasound or abbreviated MRI
Abdominal ultrasound or abbreviated MRI
|
Outcome Measures
Primary Outcome Measures
- Compliance with screening protocol [12 months]
Compliance with conducting all three screening tests
- Feasibility of screening protocol [12 months]
Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system
Eligibility Criteria
Criteria
Inclusion Criteria:
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Cirrhosis, any etiology, or chronic HBV infection
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High risk of HCC
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Age 18-75
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Competent to provide informed consent
Exclusion Criteria:
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Prior diagnosis of HCC
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Current suspicion of HCC
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Prior receipt of any organ transplantation
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Participation in another HCC screening trial
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CTP score >=10
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MELD-Na score >20
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GFR<30
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Poor life expectancy (<5 years)
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Contraindication to MRI
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Inability to complete study visits
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Currently pregnant
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cherokee Nation Health Service | Tahlequah | Oklahoma | United States | 74464 |
Sponsors and Collaborators
- University of Washington
- National Cancer Institute (NCI)
- Cherokee Nation Health Services
- Alaska Native Tribal Health Consortium
Investigators
- Principal Investigator: George Ioannou, MD, MS, University of Washington
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00013583
- 1P20CA252732-01A1