NCT05304234 Liver Cancer Disparities in American Indian and Alaska Native Persons
| NCT ID | NCT05304234 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Washington |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2025-09-01 |
Trial Parameters
Eligibility Fast-Check
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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.
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
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