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

Recruiting

• Conditions: Cancer, Hepatocellular
• Interventions: Diagnostic Test: GAAD score

• Registration Number: NCT06601231
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-18
• Study First Submitted: 2024-04-22
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-13
• Last Update Submitted: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2027-04-18
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
all patients who are eligible for HCC surveillance	GAAD score	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)

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change in GAAD score over time in relation to confounding factors	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.

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, CA, Netherlands