NCT05304234

Liver Cancer Disparities in American Indian and Alaska Native Persons

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatocellular Carcinoma
• Cirrhosis, Liver
• Hepatitis B

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasound or abbreviated MRI	Abdominal ultrasound or abbreviated MRI

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-09-01
• Completion: 2026-09-01
• First posted: 2022-03-31
• Last updated: 2024-06-04

Locations

1 site across 1 country: United States