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NCT Number: NCT06601231

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

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.

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Key information

Conditions

Cancer, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GAAD score

Diagnostic Test

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).

Primary outcomes

  1. The diagnostic value of the GAAD score for HCC

    Time frame: 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.

Secondary outcomes

  1. Change in GAAD score over time in relation to confounding factors

    Time frame: 3 years

    Change in GAAD score over time in relation to confounding factors will be analysed using pairwise comparisons and linear regression. The following confounding factors will be analysed: age in years, gender, ALT, creatinine umol/L and bilirubin U/L. The proportion of patients with a GAAD score above the cut-off will be shown using descriptive statistics. The association between the occurrence of HCC in relation to the change in GAAD score, (from below to above the cut-off score) will be expressed using sensitivity, specificity, positive and negative predictive values as described above.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Moussa, MD

CONTACT

[email protected]

0685529560

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: ADRENALIN

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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