Use of Gender, Age, Alfa-fetoprotein (AFP), and Des-gamma-carboxyprothrombin (PIVKA-II) or GAAD Score in Addition to Ultrasound for Surveillance of People At-risk for Developing Hepatocellular Carcinoma in Asia in Order to Detect Early Liver Cancer

NCT07298577 | Enrolling By Invitation

• 1 other identifier: Si089/2024
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief Summary

HCC surveillance is currently limited by underutilization and the suboptimal performance of AFP. This prospective, single-arm study investigates whether the GAAD score (Gender, Age, AFP, and PIVKA-II) enhances HCC detection when added to standard-of-care surveillance. High-risk patients will undergo US plus GAAD score testing every six months for two years. The primary analysis compares the relative true positive rate (rTPR) and relative false positive rate (rFPR) of surveillance modalities (US, AFP, GAAD) against combined strategies (US+AFP; US+GAAD), utilizing a 2.57 GAAD cut-off. Secondary endpoints include longitudinal biomarker kinetics, early-stage HCC detection rates, and the impact on downstream imaging (CT/MRI) volume. Ultimately, this study seeks to define the role of GAAD as a surveillance adjunct and inform future clinical guidelines for biomarker-enhanced HCC screening.

Conditions

Liver Cirrhosis; Hepatitis B, Chronic; Hepatitis C, Chronic; Carcinoma, Hepatocellular

Keywords

Hepatocellular carcinoma, liver cirrhosis, GAAD score

Outcome Measures

Primary Outcomes (3)

• Occurrence of hepatocellular carcinoma (HCC)

  New HCC detected by imaging or pathology

  24 months of follow up

• Relative True Positive Rate of Surveillance Modalities

  24 months

• Relative False Positive Rate of Surveillance Modalities

  24 months

Study Arms (1)

Addition of PIVKA-II and GAAD score to all participants

EXPERIMENTAL

Addition of PIVKA-II and GAAD score will probably detect more HCC and compare with ultrasound alone or ultrasound plus AFP

Diagnostic Test: PIVKA-II and GAAD score calculation

Interventions

PIVKA-II and GAAD score calculation DIAGNOSTIC_TEST

Measurement of PIVKA-II to routine ultrasound and AFP and calculation of GAAD score

Addition of PIVKA-II and GAAD score to all participants

Eligibility Criteria

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

You may qualify if:

• Signed informed consent form (ICF).
• Age above 18 years.
• Patients with chronic liver disease who have an indication for HCC surveillance, including:
• Liver cirrhosis of any etiology (e.g., chronic HBV, HCV, NASH, alcohol).
• Non-cirrhotic chronic liver disease (HCV, MASH, ALD) with evidence of F3 stage fibrosis.
• Chronic HBV infection with a clinical diagnosis of non-cirrhosis

You may not qualify if:

• Diagnosis with any cancer other than non-melanoma skin cancer.
• Pre-existing diagnosed malignancies, including previous HCC.
• Life expectancy of less than 2 years.
• Use of Vitamin K antagonists within one week before enrolment.
• Women who are pregnant or lactating.
• Glomerular filtration rate (GFR) \< 60 mL/min/1.73 m².
• Significant hepatic decompensation or a Child-Pugh score of C.
• Unwillingness or inability to undergo CT and MRI imaging.
• Unwillingness to participate in the study.

Sponsors & Collaborators

• Siriraj Hospital: lead
• Roche Global Development: collaborator

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis B, Chronic; Hepatitis C, Chronic; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Chronic Disease; Disease Attributes; Hepatitis C; Flaviviridae Infections; RNA Virus Infections; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 23, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 2, 2029
• Study Completion (Estimated): July 31, 2030
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)