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Liver Cancer Screening in American Indian and Alaska Native Persons

This study is looking at different ways to screen for liver cancer (Hepatocellular Carcinoma or HCC) in American Indian and Alaska Native individuals who have cirrhosis or chronic Hepatitis B. Researchers are comparing the current standard screening method, which uses ultrasound (US) and a blood test called AFP every six months, with a newer method that uses an abbreviated MRI (aMRI) and AFP every six months. The main goal is to see how well people follow each screening plan and how practical each plan is over 12 months. You might be able to join if you are between 18 and 75 years old, have cirrhosis or chronic Hepatitis B, and have a high risk of HCC. The study is currently unclear on its recruitment status.

Study design
This is a pilot and feasibility randomized controlled trial, meaning participants will be randomly assigned to one of two screening groups. It plans to enroll 200 participants.
What's involved
Participants will undergo screening tests (either US + AFP or aMRI + AFP) at the start of the study, at 6 months, and at 12 months.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes related to screening compliance and feasibility will be measured at 12 months.

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NCT05304234

Liver Cancer Disparities in American Indian and Alaska Native Persons

Recruiting
PHASE2Ages 18–75InterventionalScreening
University of Washington
~200 participants
Updated 2024-06-04 on ClinicalTrials.gov
What's tested:Ultrasound or abbreviated MRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compliance with screening protocol
Measured over 12 months
+1 more outcome measured

Conditions

Hepatocellular Carcinoma
Cirrhosis, Liver
Hepatitis B

Explore related trials

CirrhosisHepatitis B Infection

Where it's being run

1 sites across 1 states
Oklahoma1

Study leadership

  • George Ioannou, MD, MS · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Jennifer R Harry
[email protected]
206-616-0397
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cirrhosis, any etiology, or chronic HBV infection
High risk of HCC
Age 18-75
Competent to provide informed consent

Exclusion

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

What this trial measures

  • Compliance with screening protocol12 months

    Compliance with conducting all three screening tests

  • Feasibility of screening protocol12 months

    Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system