NCT07298577Enrolling by invitation
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
A Prospective, Interventional, Longitudinal Asia Pacific Study Evaluating Clinical Utility of Des-gamma-carboxyprothrombin (PIVKA-II) or GAAD Score Plus Ultrasound for Detection of Hepatocellular Carcinoma (HCC) in a High-risk Patient Population
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 2100 (estimated)
- First submitted
- 6 Dec 2025
- Start date
- 2 Feb 2026
- Primary completion date
- 2 Feb 2029
- Lead sponsor
- Siriraj Hospital
- NCT number
- NCT07298577
What you commit to
- Study type: Interventional
- Planned participants: 2100
- From 2 Feb 2026 to the primary completion date, 2 Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-existing diagnosed malignancies, including previous HCC.
- Use of Vitamin K antagonists within one week before enrolment.
Other illness
- Diagnosis with any cancer other than non-melanoma skin cancer.
Lab values
- Glomerular filtration rate (GFR) \< 60 mL/min/1.73 m².
Other
- Life expectancy of less than 2 years.
- Women who are pregnant or lactating.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok Noi | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.