Actively Recruiting
Comparing Liver Cancer Screening Methods Using Ultrasound Plus AFP Versus Abbreviated MRI Plus AFP in American Indian and Alaska Native Adults with Cirrhosis or Hepatitis B
Led by University of Washington · Updated on 2024-06-04
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a pilot and feasibility randomized controlled trial to compare two methods of screening for hepatocellular carcinoma HCC among American Indian and Alaska Native AIAN patients with cirrhosis or chronic hepatitis B virus infection. This study aims to evaluate the compliance and feasibility of screening protocols using abdominal ultrasound plus serum alpha-fetoprotein AFP testing versus abbreviated magnetic resonance imaging aMRI plus AFP testing every six months for one year. The trial will also assess the proportion of tests using appropriate protocols with LI-RADS documentation and the rate and stage of HCC diagnosis. Participants are randomly assigned to one of two groups one receiving abdominal ultrasound and AFP testing at baseline, 6 months, and 12 months the other receiving abbreviated MRI of the abdomen plus AFP testing at the same intervals. The study duration is 12 months, with screening conducted three times. Both screening methods are diagnostic tests evaluated under this trial. During the study, participants will undergo screening tests at three timepoints to monitor liver cancer risk and screen for HCC. Researchers will assess adherence to the screening schedule and the quality of test documentation. The primary outcomes include compliance with and feasibility of the screening protocols over 12 months. Safety and participant ability to complete visits will be monitored throughout, ensuring comprehensive data collection and follow-up within the study period.
CONDITIONS
Brief Title
Liver Cancer Disparities in American Indian and Alaska Native Persons
Research Team
J
Jennifer R Harry
S
Stephanie Y Park
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