Liver Cancer Disparities in American Indian and Alaska Native Persons

Hepatocellular Carcinoma Clinical Trial

Official title:

Liver Cancer Disparities in American Indian and Alaska Native Persons

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304234
• Other study ID #: STUDY00013583
• Secondary ID: 1P20CA252732-01A
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2022
• Est. completion date: September 1, 2026

Study information

• Verified date: June 2024
• Source: University of Washington
• Contact: Jennifer R Harry
• Phone: 206-616-0397
• Email: jharry[@]medicine.washington.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Hepatitis B
• Hepatocellular Carcinoma
• Liver Cirrhosis
• Liver Neoplasms

Intervention

Diagnostic Test:
• Ultrasound or abbreviated MRI
Abdominal ultrasound or abbreviated MRI

Locations

Country	Name	City	State
United States	Cherokee Nation Health Service	Tahlequah	Oklahoma

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Alaska Native Tribal Health Consortium, Cherokee Nation Health Services, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with screening protocol	Compliance with conducting all three screening tests	12 months
Primary	Feasibility of screening protocol	Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system	12 months