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Liver Cancer Disparities in American Indian and Alaska Native Persons

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ClinicalTrials.gov Identifier: NCT05304234
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : June 15, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cherokee Nation Health Services
Alaska Native Tribal Health Consortium
Information provided by (Responsible Party):
George Ioannou, University of Washington

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Cirrhosis, Liver Hepatitis B Diagnostic Test: Ultrasound or abbreviated MRI Phase 2

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:

  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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Screening
Official Title: Liver Cancer Disparities in American Indian and Alaska Native Persons
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Active Comparator: Ultrasound + AFP
Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months
Diagnostic Test: Ultrasound or abbreviated MRI
Abdominal ultrasound or abbreviated MRI

Active Comparator: aMRI + AFP
Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months
Diagnostic Test: Ultrasound or abbreviated MRI
Abdominal ultrasound or abbreviated MRI




Primary Outcome Measures :
  1. Compliance with screening protocol [ Time Frame: 12 months ]
    Compliance with conducting all three screening tests

  2. Feasibility of screening protocol [ Time Frame: 12 months ]
    Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05304234


Contacts
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Contact: Jennifer R Harry 206-616-0397 jharry@medicine.washington.edu
Contact: Stephanie Y Park 206-744-7050 sypark22@uw.edu

Locations
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United States, Oklahoma
Cherokee Nation Health Service Recruiting
Tahlequah, Oklahoma, United States, 74464
Contact: Jorge Mera         
Contact: Whitney Essex         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Cherokee Nation Health Services
Alaska Native Tribal Health Consortium
Investigators
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Principal Investigator: George Ioannou, MD, MS University of Washington
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Responsible Party: George Ioannou, Professor, School of Medicine, Gastroenterology, University of Washington
ClinicalTrials.gov Identifier: NCT05304234    
Other Study ID Numbers: STUDY00013583
1P20CA252732-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Liver Neoplasms
Liver Cirrhosis
Hepatitis
Liver Diseases
Digestive System Diseases
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Blood-Borne Infections
Communicable Diseases
Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Fibrosis
Pathologic Processes