Status:

RECRUITING

Liver Cancer Disparities in American Indian and Alaska Native Persons

Lead Sponsor:

University of Washington

Collaborating Sponsors:

National Cancer Institute (NCI)

Cherokee Nation Health Services

Conditions:

Hepatocellular Carcinoma

Cirrhosis, Liver

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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) ...

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) ...

Eligibility Criteria

Inclusion

  • Cirrhosis, any etiology, or chronic HBV infection
  • High risk of HCC
  • Age 18-75
  • Competent to provide informed consent

Exclusion

  • 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

Key Trial Info

Start Date :

April 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT05304234

Start Date

April 1 2022

End Date

September 1 2026

Last Update

June 4 2024

Active Locations (1)

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Cherokee Nation Health Service

Tahlequah, Oklahoma, United States, 74464