NCT05304234 · University of Washington
Liver Cancer Disparities in American Indian and Alaska Native Persons
What this study is about
We are performing a pilot and feasibility randomly assigned 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.
View original scientific 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.
Interventions
DIAGNOSTIC_TEST
Ultrasound or abbreviated MRI
Abdominal ultrasound or abbreviated MRI
Primary outcome measures
Compliance with screening protocol
Time frame: 12 months
Compliance with conducting all three screening tests
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Cirrhosis, any etiology, or chronic HBV infection
- High risk of HCC
- 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
- Poor life expectancy (\<5 years)
- Contraindication to MRI
- Inability to complete study visits
- Currently pregnant
Where
- Tahlequah, Oklahoma
Collaborators
National Cancer Institute (NCI), Cherokee Nation Health Services, Alaska Native Tribal Health Consortium
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2024 · Source of record for eligibility and locations