To Quantify the Impact of Addition of the GAAD Score to Imaging in Patients with Chronic Liver Disease Eligible for HCC Surveillance.

Recruiting now

Conditions studied: Cancer, Hepatocellular

In brief

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.

Key facts

Study ID

NCT06601231

Run by

Erasmus Medical Center

People needed

1000

Starts

2024-03-18

Expected to finish

2027-07-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Erasmus MC — Rotterdam, CA, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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