Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 2

Liver Cancer Disparities in American Indian and Alaska Native Persons

NCT ID: NCT05304234Sponsor: University of WashingtonLast updated: 2024-06-04

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.

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

Arms & interventions

  • Diagnostic TestUltrasound or abbreviated MRI

    Abdominal ultrasound or abbreviated MRI

Outcome measures

Primary

  • Compliance with screening protocol

    Compliance with conducting all three screening tests

    Time frame: 12 months

  • Feasibility of screening protocol

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

    Time frame: 12 months

Eligibility criteria

Sex: AllAge: 18 Years to 75 YearsHealthy 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

Study locations (1)

Cherokee Nation Health Service

Tahlequah, Oklahoma, 74464

Recruiting
Jorge Mera · Contact
Whitney Essex · Contact
Liver Cancer Disparities in American Indian and Alaska Native Persons | Cancerify