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

NCT06601231 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-09-19

No results posted yet for this 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.

Conditions

  • Cancer, Hepatocellular

Interventions

DIAGNOSTIC_TEST

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).

Sponsors & Collaborators

Principal Investigators

  • M. J. Sonneveld, MD, PhD · Erasmus Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2027-04-18
Completion
2027-07-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06601231 on ClinicalTrials.gov