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

NCT06601231 | Recruiting DMC

• 1 other identifier: NL85202.078.23
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Hepatocellular

Keywords

GAAD score; early detection

Outcome Measures

Primary Outcomes (1)

• The diagnostic value of the GAAD score for HCC

  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.

  6 months

Secondary Outcomes (1)

• Change in GAAD score over time in relation to confounding factors

  3 years

Study Arms (1)

all patients who are eligible for HCC surveillance

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)

Diagnostic Test: GAAD score

Interventions

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).

all patients who are eligible for HCC surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, CA, Netherlands

RECRUITING

Related Publications (4)

• 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.

  PMID: 29628281 BACKGROUND

• 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.

  PMID: 30464023 BACKGROUND

• 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.

  PMID: 37938100 BACKGROUND

• 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.

  PMID: 8870764 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample material is obtained during regular blood assessment. For the purpose of biobanking, a maximum of 20mL of additional blood will be drawn and stored in for future studies. The central biobank has given approval for the storage of the samples.

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• M. J. Sonneveld, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Moussa, MD

CONTACT

0685529560; m.moussa@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: September 19, 2024
• Study Start: March 18, 2024
• Primary Completion (Estimated): April 18, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

NL (1)