Liver Cancer Disparities in American Indian and Alaska Native Persons

Hepatocellular Carcinoma Clinical Trial

Official title: Liver Cancer Disparities in American Indian and Alaska Native Persons

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Hepatitis B
• Hepatocellular Carcinoma
• Liver Cirrhosis
• Liver Neoplasms

• NCT number: NCT05304234
• Study type: Interventional
• Source: University of Washington
• Contact: Jennifer R Harry
• Phone: 206-616-0397
• Email: jharry@medicine.washington.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2022
• Completion date: September 1, 2026