Liver Cancer Disparities in American Indian and Alaska Native Persons

June 13, 2022 updated by: George Ioannou, University of Washington
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Tahlequah, Oklahoma, United States, 74464
        • Recruiting
        • Cherokee Nation Health Service
        • Contact:
          • Jorge Mera
        • Contact:
          • Whitney Essex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound + AFP
Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months
Diagnostic test: Ultrasound or abbreviated MRI
Abdominal ultrasound or abbreviated MRI
Active Comparator: aMRI + AFP
Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months
Diagnostic test: Ultrasound or abbreviated MRI
Abdominal ultrasound or abbreviated MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance with screening protocol
Time Frame: 12 months
Compliance with conducting all three screening tests
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

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

Investigators

  • Principal Investigator: George Ioannou, MD, MS, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00013583
  • 1P20CA252732-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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