RecruitingPhase 2NCT05304234
Liver Cancer Disparities in American Indian and Alaska Native Persons
Sponsor
University of Washington
Enrollment
200 participants
Start Date
Apr 1, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- Cirrhosis, any etiology, or chronic HBV infection
- High risk of HCC
- Age 18-75
- Competent to provide informed consent
Exclusion Criteria11
- 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
- GFR\<30
- Poor life expectancy (\<5 years)
- Contraindication to MRI
- Inability to complete study visits
- Currently pregnant
Interventions
DIAGNOSTIC_TESTUltrasound or abbreviated MRI
Abdominal ultrasound or abbreviated MRI
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05304234
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