Status:
RECRUITING
To Quantify the Impact of Addition of the GAAD Score to Imaging in Patients with Chronic Liver Disease Eligible for HCC Surveillance.
Lead Sponsor:
Erasmus Medical Center
Conditions:
Cancer, Hepatocellular
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this prospective observational study is to test the impact of addition of the GAAD score to imaging in patients with chronic liver disease eligible for HCC surveillance. The main questions...
Eligibility Criteria
Inclusion
- All patients with cirrhosis
- Non-cirrhotic chronic hepatitis B patients meeting any of the following criteria: positive family history for HCC, intermediate-high aMAP and/or (m)PAGE-B score (if non-Caucasian)
- Non-cirrhotic chronic hepatitis C patients (with or without SVR) with a history of F3 fibrosis (based on histology or liver stiffness assessment)
- Non-cirrhotic NASH patients with a history of F3 fibrosis (based on histology or liver stiffness assessment)
Exclusion
- Diagnosis with any other cancer other than non-melanoma skin cancer
- History of HCC
- Women who are pregnant or lactating
- Patient with glomerular filtration rate \<45 ml /min/1.73 m2
- Unwillingness or inability to undergo both CT and MRI imaging
- Life expectancy \<2 years
- Use of vitamin K antagonists
Key Trial Info
Start Date :
March 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06601231
Start Date
March 18 2024
End Date
July 1 2027
Last Update
September 19 2024
Active Locations (1)
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1
Erasmus MC
Rotterdam, CA, Netherlands