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NCT05304234PHASE2Recruiting

Liver Cancer Disparities in American Indian and Alaska Native Persons

University of Washington

Start Date

4/1/2022

Completion Date

9/1/2026

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: 1. Compliance/feasibility of conducting all three screening tests (0, 6 and 12 months) - Primary Outcome 2. Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system - Primary Outcome 3. Proportion diagnosed with HCC and stage at diagnosis - Secondary Outcome

Eligibility Criteria

Age Range: 18 years to 75 years

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 * GFR\<30 * Poor life expectancy (\<5 years) * Contraindication to MRI * Inability to complete study visits * Currently pregnant

Interventions

DIAGNOSTIC_TEST

Ultrasound or abbreviated MRI

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Conditions

Hepatocellular CarcinomaCirrhosis, LiverHepatitis B

Locations

Cherokee Nation Health Service

Tahlequah, Oklahoma 74464

United States