Liver Cancer Disparities in American Indian and Alaska Native Persons

Part of paid clinical trials in Tahlequah, Oklahoma.

Sponsor
University of Washington
Study ID
NCT05304234
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound or abbreviated MRI — DIAGNOSTIC_TEST
    Abdominal ultrasound or abbreviated MRI

Study Details

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.

Key Dates

Start date
Apr 1, 2022
Status verified
Jun 2024
Primary completion
Sep 1, 2025
Completion
Sep 1, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: Ultrasound + AFP
    Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months
  • Active Comparator: aMRI + AFP
    Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months

Primary Outcome Measure

Compliance with screening protocol [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cherokee Nation Health ServiceTahlequahOklahoma74464
Jorge Mera
Whitney Essex

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