Screening for liver cancer in American Indian and Alaska Native patients
Liver Cancer Disparities in American Indian and Alaska Native Persons
PHASE2 · University of Washington · NCT05304234
This study is testing two different ways to screen for liver cancer in American Indian and Alaska Native patients who have cirrhosis or chronic hepatitis B to see which method works better for early detection.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Washington (other) |
| Locations | 1 site (Tahlequah, Oklahoma) |
| Trial ID | NCT05304234 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to evaluate the feasibility and compliance of two screening methods for hepatocellular carcinoma (HCC) among American Indian and Alaska Native patients with cirrhosis or chronic hepatitis B. Participants will be randomly assigned to receive either the standard ultrasound plus alpha-fetoprotein (AFP) testing or an abbreviated MRI plus AFP testing every six months over a 12-month period. The study will assess the proportion of screenings conducted according to protocol and the rate of HCC diagnoses, focusing on improving early detection in a high-risk population.
Who should consider this trial
Good fit: Ideal candidates are American Indian and Alaska Native individuals aged 18-75 with cirrhosis or chronic hepatitis B infection.
Not a fit: Patients with a prior diagnosis of HCC or those with contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection of liver cancer in a vulnerable population, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown success with similar screening approaches, indicating potential for effective early detection strategies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tahlequah, Oklahoma
- Cherokee Nation Health Service — Tahlequah, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: George Ioannou, MD, MS — University of Washington
- Study coordinator: Jennifer R Harry
- Email: jharry@medicine.washington.edu
- Phone: 206-616-0397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatocellular Carcinoma, Cirrhosis, Liver, Hepatitis B