NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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 InvitationNA

Sponsor: Siriraj Hospital

Conditions: Liver Cirrhosis, Hepatitis B, Chronic, Hepatitis C, Chronic, Carcinoma, Hepatocellular

Interventions: PIVKA-II and GAAD score calculation

Countries: Thailand

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Locations (1)

Bangkok Noi, Bangkok, Thailand