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NCT Number: NCT05304234

Liver Cancer Disparities in American Indian and Alaska Native Persons

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.

Recruiting

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Key information

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound or abbreviated MRI

Diagnostic Test

Abdominal ultrasound or abbreviated MRI

Primary outcomes

  1. Compliance with screening protocol

    Time frame: 12 months

    Compliance with conducting all three screening tests

  2. Feasibility of screening protocol

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer R Harry

CONTACT

[email protected]

206-616-0397

Stephanie Y Park

CONTACT

[email protected]

206-744-7050

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Alaska Native Tribal Health Consortium
  • Cherokee Nation Health Services
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 31, 2022
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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