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Clinical Trials in the Netherlands / NCT06601231
Recruiting Observational

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

NCT06601231 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Erasmus Medical Center
Phase
Observational
Started
2024-03-18
Last updated
2024-09-19

Condition(s) studied

Cancer, Hepatocellular

Investigational drug(s) / intervention(s)

GAAD score

GAAD 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).

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The diagnostic value of the GAAD score for HCC — 6 months
    The diagnostic value of the GAAD score for HCC will be expressed using sensitivity, specificity, positive and negative predictive values, both overall and for the subgroup of early stage (BCLC 0-A) HCC. The GAAD scores will be measured and documented separately for each visit. The diagnostic value of the GAAD score will be assessed for HCC diagnosed at the index visit (ie the visit at which the GAAD score was determined) and for HCC diagnosed on imaging performed at 6 months after the index visit.

Trial sites (1)

FacilityCityRegionStatus
Erasmus MC Rotterdam CA Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06601231 on ClinicalTrials.gov ↗ ← All trials in the Netherlands