Liver Cancer Disparities in American Indian and Alaska Native Persons
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound or abbreviated MRI.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Cirrhosis, Liver, Hepatitis B. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Diagnostic test Ultrasound or abbreviated MRI
Abdominal ultrasound or abbreviated MRI
Primary outcome measures
- Compliance with screening protocol [Time frame: 12 months]
- Feasibility of screening protocol [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Cherokee Nation Health Service — Tahlequah
Identifiers
NCT: NCT05304234 · STUDY00013583 · 1P20CA252732-01A1