Liver Cancer Disparities in American Indian and Alaska Native Persons
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- University of Washington
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Compliance with screening protocol
Study Overview
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.
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:
- Compliance/feasibility of conducting all three screening tests (0, 6 and 12 months) - Primary Outcome
- Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system - Primary Outcome
- Proportion diagnosed with HCC and stage at diagnosis - Secondary Outcome
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cirrhosis, any etiology, or chronic HBV infection
- •High risk of HCC
- •Age 18-75
- •Competent to provide informed consent
Exclusion Criteria
- •Prior diagnosis of HCC
- •Current suspicion of HCC
- •Prior receipt of any organ transplantation
- •Participation in another HCC screening trial
- •CTP score >=10
- •MELD-Na score >20
- •Poor life expectancy (<5 years)
- •Contraindication to MRI
- •Inability to complete study visits
- •Currently pregnant
Outcomes
Primary Outcomes
Compliance with screening protocol
Time Frame: 12 months
Compliance with conducting all three screening tests
Feasibility of screening protocol
Time Frame: 12 months
Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system
Secondary Outcomes
No secondary outcomes reported
Investigators
George Ioannou
Professor, School of Medicine, Gastroenterology
University of Washington