To study the impact of addition of the GAAD score to imaging in patients with chronic liver disease eligible for HCC surveillance.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy of the GAAD score (cut-off 2.57) for detection of HCC
(overall and by BCLC stage), expressed using sensitivity, specificity, negative
predictive value and positive predictive value.
Secondary outcome
nvt
Background summary
Hepatocellullar carcinoma (HCC) is a major cause of death among patients with
chronic liver disease. Current guidelines therefore recommend 6 monthly HCC
surveillance using liver imaging in all patients with cirrhosis, and in a
subset of non-cirrhotic patients with chronic hepatitis B, chronic hepatitis C
or NASH (1). Since the sensitivity of liver imaging is limited, guidelines
suggest addition of biomarkers to imaging to increase the probability of
detecting early-stage HCC. Recent studies indicate that a risk score comprising
patient gender, age, and AFP with AFP-L3 and des-carboxy-prothrombin (the GALAD
score) has superior diagnostic accuracy, and could help improve HCC detection
(2). A simplified version of GALAD, the GAAD score, was recently shown to yield
comparable results, and has subsequently been implemented in liver clinics (3).
References:
1. European Association for the Study of the Liver. Electronic address eee,
European Association for the Study of the L. EASL Clinical Practice Guidelines:
Management of hepatocellular carcinoma. J Hepatol. 2018;69(1):182-236.
2. Yang JD, Addissie BD, Mara KC, Harmsen WS, Dai J, Zhang N, et al. GALAD
Score for Hepatocellular Carcinoma Detection in Comparison with Liver
Ultrasound and Proposal of GALADUS Score. Cancer Epidemiol Biomarkers Prev.
2019;28(3):531-8.
3. Lik-Yuen Chan H, Berg T, De Toni EN, Kudo M, Trojan J et al. A comparative
analysis of Elecsys GALAD and Elecsys GAAD score to detect early-stage
hepatocellular carcinoma in an international cohort. 2022.
Study objective
To study the impact of addition of the GAAD score to imaging in patients with
chronic liver disease eligible for HCC surveillance.
Study design
Prospective cohort study.
Study burden and risks
The GAAD score is already available in the clinic and assessed in patients
eligible for HCC surveillance regardless of participation in this study.
Participation in this follow-up study is not associated with additional risks
to the patient.
Dr. Molenwaterplein 40
Rotterdam 3015 GD
NL
Dr. Molenwaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- All patients with cirrhosis
- Non-cirrhotic chronic hepatitis B patients meeting any of the following
criteria: positive family history for hepatocellular carcinoma,
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 hepatocellular carcinoma
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85202.078.24 |