Clinical trial · Interventional
Liver Cancer Disparities in American Indian and Alaska Native Persons
NCT05304234CI-TRIAL-00077717unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis, Liver | — | UNRESOLVED | — |
| Hepatitis B | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound or abbreviated MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ultrasound + AFP
- description
- Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months
- interventionNames
- Diagnostic Test: Ultrasound or abbreviated MRI
- type
- ACTIVE_COMPARATOR
- label
- aMRI + AFP
- description
- Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months
- interventionNames
- Diagnostic Test: Ultrasound or abbreviated MRI
Primary outcomes (2)
- measure
- Compliance with screening protocol
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.