Liver Cancer Disparities in American Indian and Alaska Native Persons

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT05304234
Collaborator
National Cancer Institute (NCI) (NIH), Cherokee Nation Health Services (Other), Alaska Native Tribal Health Consortium (Other)
200
1
2
36
5.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound or abbreviated MRI
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model 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 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.
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Liver Cancer Disparities in American Indian and Alaska Native Persons
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Compliance with screening protocol [12 months]

    Compliance with conducting all three screening tests

  2. Feasibility of screening protocol [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cherokee Nation Health Service Tahlequah Oklahoma United States 74464

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
George Ioannou, Professor, School of Medicine, Gastroenterology, University of Washington
ClinicalTrials.gov Identifier:
NCT05304234
Other Study ID Numbers:
  • STUDY00013583
  • 1P20CA252732-01A1
First Posted:
Mar 31, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022