Clinical trial NCT06601231: To Quantify the Impact of Addition of the GAAD Score to Imaging in Patients with Chronic Liver Disease Eligible for HCC Surveillance.
Official title: Addition of GAAD Score to Imaging Surveillance for Early Identification of Liver Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer, Hepatocellular
Keywords: GAAD score
early detection
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult (18 years or older) patients with chronic liver disease, with an indication for HCC surveillance, are potentially eligible for enrolment.

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.


Eligibility criteria: 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 outcomes:
measure: The diagnostic value of the GAAD score for HCC
timeFrame: 6 months
Secondary outcomes:
measure: Change in GAAD score over time in relation to confounding factors
timeFrame: 3 years
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: CA
Study officials:
affiliation: Erasmus Medical Center
name: M. J. Sonneveld, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.
citation: Yang JD, Addissie BD, Mara KC, Harmsen WS, Dai J, Zhang N, Wongjarupong N, Ali HM, Ali HA, Hassan FA, Lavu S, Cvinar JL, Giama NH, Moser CD, Miyabe K, Allotey LK, Algeciras-Schimnich A, Theobald JP, Ward MM, Nguyen MH, Befeler AS, Reddy KR, Schwartz M, Harnois DM, Yamada H, Srivastava S, Rinaudo JA, Gores GJ, Feng Z, Marrero JA, Roberts LR. GALAD Score for Hepatocellular Carcinoma Detection in Comparison with Liver Ultrasound and Proposal of GALADUS Score. Cancer Epidemiol Biomarkers Prev. 2019 Mar;28(3):531-538. doi: 10.1158/1055-9965.EPI-18-0281. Epub 2018 Nov 21.
citation: Piratvisuth T, Hou J, Tanwandee T, Berg T, Vogel A, Trojan J, De Toni EN, Kudo M, Eiblmaier A, Klein HG, Hegel JK, Madin K, Kroeniger K, Sharma A, Chan HLY. Development and clinical validation of a novel algorithmic score (GAAD) for detecting HCC in prospective cohort studies. Hepatol Commun. 2023 Nov 8;7(11):e0317. doi: 10.1097/HC9.0000000000000317. eCollection 2023 Nov 1.
citation: Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med. 1996 Sep;3(9):895-900. doi: 10.1111/j.1553-2712.1996.tb03538.x.