Actively Recruiting
To Quantify the Impact of Addition of the GAAD Score to Imaging in Patients with Chronic Liver Disease Eligible for HCC Surveillance.
Led by Erasmus Medical Center · Updated on 2024-09-19
1000
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 it aims to answer are: * Diagnostic accuracy of the GAAD score (cut-off 2.57 (3)) for detection of HCC (overall and by BCLC stage), expressed using sensitivity, specificity, negative predictive value and positive predictive value. * Change in GAAD score over time, and proportion of patients with a GAAD score above the cut-off over time in relation to potential confounding factors (e.g. age, bilirubin levels, presence of HCC). 1000 participants with chronic liver disease eligible for HCC surveillance will be enrolled. Data will be collected for 3 consecutive years after enrollment. As per clinical practice, patients will undergo standard bi-annual HCC surveillance comprising liver imaging with ultrasound (or CT or MRI based on previous investigations) and GAAD score assessment based on blood samples.
CONDITIONS
Official Title
To Quantify the Impact of Addition of the GAAD Score to Imaging in Patients with Chronic Liver Disease Eligible for HCC Surveillance.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with cirrhosis
- Non-cirrhotic chronic hepatitis B patients with either a positive family history for HCC, intermediate-high aMAP score, or (m)PAGE-B score if non-Caucasian
- Non-cirrhotic chronic hepatitis C patients with or without sustained virologic response and history of F3 fibrosis confirmed by histology or liver stiffness
- Non-cirrhotic NASH patients with history of F3 fibrosis confirmed by histology or liver stiffness
You will not qualify if you...
- Diagnosis of any other cancer except non-melanoma skin cancer
- History of hepatocellular carcinoma (HCC)
- Pregnant or lactating women
- Patients with glomerular filtration rate less than 45 ml/min/1.73 m2
- Unwilling or unable to undergo both CT and MRI imaging
- Life expectancy less than 2 years
- Use of vitamin K antagonists
AI-Screening
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Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, CA, Netherlands
Actively Recruiting
Research Team
M
Mohamed Moussa, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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