RecruitingNCT06601231

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

Addition of GAAD Score to Imaging Surveillance for Early Identification of Liver Cancer.


Sponsor

Erasmus Medical Center

Enrollment

1,000 participants

Start Date

Mar 18, 2024

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a blood test called the GAAD score to standard liver imaging can better identify which patients with chronic liver disease (such as cirrhosis or hepatitis) are at high risk for developing liver cancer (hepatocellular carcinoma, or HCC), so it can be caught earlier. **You may be eligible if...** - You have cirrhosis (scarring of the liver) from any cause, OR - You have chronic hepatitis B (without cirrhosis) with a family history of liver cancer or certain elevated risk scores, OR - You have chronic hepatitis C or fatty liver disease (NASH) with advanced liver scarring (F3 fibrosis) **You may NOT be eligible if...** - You have been diagnosed with any cancer other than non-melanoma skin cancer - You have a prior history of liver cancer - You are pregnant or breastfeeding - Your kidney function is significantly reduced (GFR below 45) - You are unable or unwilling to undergo both CT and MRI imaging - Your life expectancy is less than 2 years - You take warfarin or similar blood thinners (vitamin K antagonists) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTGAAD score

In order to calculate the GAAD score an in-vitro diagnostic is used. The Elecsys GAAD assay by Roche Diagnostics is used to assess the GAAD score using on blood samples collected from patients during regular outpatient clinic visits. The Elecsys GAAD test combines the results of the Elecsys PIVKA-II and Elecsys AFP assays with gender and age (the GAAD score is calculated with PIVKA-II, AFP, gender and age).


Locations(1)

Erasmus MC

Rotterdam, CA, Netherlands

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NCT06601231