Liver Cancer Disparities in American Indian and Alaska Native Persons
Primary Purpose
Hepatocellular Carcinoma, Cirrhosis, Liver, Hepatitis B
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ultrasound or abbreviated MRI
Sponsored by
About this trial
This is an interventional screening trial for Hepatocellular Carcinoma
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
Sites / Locations
- Cherokee Nation Health ServiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ultrasound + AFP
aMRI + AFP
Arm Description
Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months
Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months
Outcomes
Primary Outcome Measures
Compliance with screening protocol
Compliance with conducting all three screening tests
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05304234
First Posted
March 22, 2022
Last Updated
June 13, 2022
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI), Cherokee Nation Health Services, Alaska Native Tribal Health Consortium
1. Study Identification
Unique Protocol Identification Number
NCT05304234
Brief Title
Liver Cancer Disparities in American Indian and Alaska Native Persons
Official Title
Liver Cancer Disparities in American Indian and Alaska Native Persons
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI), Cherokee Nation Health Services, Alaska Native Tribal Health Consortium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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) 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:
Compliance/feasibility of conducting all three screening tests (0, 6 and 12 months) - Primary Outcome
Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system - Primary Outcome
Proportion diagnosed with HCC and stage at diagnosis - Secondary Outcome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Cirrhosis, Liver, Hepatitis B
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound + AFP
Arm Type
Active Comparator
Arm Description
Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months
Arm Title
aMRI + AFP
Arm Type
Active Comparator
Arm Description
Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound or abbreviated MRI
Intervention Description
Abdominal ultrasound or abbreviated MRI
Primary Outcome Measure Information:
Title
Compliance with screening protocol
Description
Compliance with conducting all three screening tests
Time Frame
12 months
Title
Feasibility of screening protocol
Description
Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer R Harry
Phone
206-616-0397
Email
jharry@medicine.washington.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Y Park
Phone
206-744-7050
Email
sypark22@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Ioannou, MD, MS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cherokee Nation Health Service
City
Tahlequah
State/Province
Oklahoma
ZIP/Postal Code
74464
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Mera
First Name & Middle Initial & Last Name & Degree
Whitney Essex
12. IPD Sharing Statement
Learn more about this trial
Liver Cancer Disparities in American Indian and Alaska Native Persons
We'll reach out to this number within 24 hrs