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

Launched by ERASMUS MEDICAL CENTER · Sep 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how adding the GAAD score, a specific blood test, to regular imaging tests can help detect liver cancer (HCC) in patients who have chronic liver disease. The main aim is to see how accurate the GAAD score is in identifying liver cancer at different stages and to monitor how this score changes over time in relation to other factors, like age and liver function. The trial will involve 1,000 participants over three years, during which they will receive standard liver imaging tests, such as ultrasounds or MRIs, along with GAAD score assessments.

To be eligible for this study, participants must have cirrhosis or specific types of chronic hepatitis with a history of significant liver damage. However, those with other types of cancer (besides certain skin cancers), a previous liver cancer diagnosis, or certain health conditions may not qualify. Throughout the study, participants can expect regular check-ups and tests to monitor their liver health, which can help improve early detection of liver cancer. This trial is currently recruiting and is open to all adults aged 65 and older.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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