Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05304234

Liver Cancer Disparities in American Indian and Alaska Native Persons

Led by University of Washington · Updated on 2024-06-04

200

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Liver Cancer Disparities in American Indian and Alaska Native Persons

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cirrhosis from any cause or chronic hepatitis B infection
  • High risk of hepatocellular carcinoma
  • Age between 18 and 75 years
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Prior diagnosis of hepatocellular carcinoma
  • Current suspicion of hepatocellular carcinoma
  • Previous organ transplantation
  • Participation in another liver cancer screening trial
  • Child-Turcotte-Pugh (CTP) score of 10 or higher
  • MELD-Na score greater than 20
  • Glomerular filtration rate (GFR) less than 30
  • Life expectancy less than 5 years
  • Contraindications to MRI
  • Unable to complete study visits
  • Currently pregnant

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Trial Site Locations

Total: 1 location

1

Cherokee Nation Health Service

Tahlequah, Oklahoma, United States, 74464

Actively Recruiting

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Research Team

J

Jennifer R Harry

CONTACT

S

Stephanie Y Park

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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