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Clinical Trials in South Korea / NCT05756699
Active, not recruiting Observational

Evaluation of Proteome Multimarker Panel With Multiple Reaction Monitoring as a Surveillance for Hepatocellular Carcinoma

NCT05756699 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Observational
Started
2023-04-10
Last updated
2025-05-15

Condition(s) studied

Liver Cirrhosis

Investigational drug(s) / intervention(s)

multiple reaction monitoring (MRM)-based multimarker panel

multiple reaction monitoring (MRM)-based multimarker panel: multiple reaction monitoring (MRM)-based multimarker panel test to detect hepatocellular carcinoma

Study summary

Most current guidelines recommend hepatocellular carcinoma (HCC) surveillance with ultrasound and alpha feto-protein (AFP) every 6 months for individuals with risk factors. However, the sensitivity of ultrasound for HCC detection is significantly reduced, especially in high-risk cirrhotic patients. In this study, the investigators aim to evaluate the efficacy of multiple reaction monitoring (MRM)-based multimarker panel as a surveillance tool for HCC. During two surveillance periods (starting from the time of voluntary consent and 6 months later), participants receive ultrasound, AFP, and MRM-based multimarker panel analysis. Patients who are suspected of HCC based on one of three tests undergo a contrast-enhanced CT scan within 6 weeks. After 6 months from the second surveillance period, the investigators re-evaluate the development of HCC using contrast-enhanced CT and AFP. The diagnostic accuracy of MRM-based multimarker panel is compared to ultrasound and AFP.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with liver cirrhosis aged over 18 years, who receive regular surveillance for hepatocellular carcinoma. * Patients with Risk Index greater than 2.33, corresponding to the annual 5% risk of hepatocellular carcinoma development. * Risk Index = 1.65 (if the prothrombin activity was ≤ 75%) + 1.41 (if the age was 55 years or older) + 0.92 (if the platelet count was \< 75 X103/mm3) + 0.74 (if the presence of anti-hepatitis C virus was positive). Exclusion Criteria: * History of malignancy diagnosis including hepatocellular carcinoma * Impaired renal function (Estimated glomerular filtration rate \<30 mL/min/1.73m2) * Impaired hepatic function (Child-Pugh class C) * Patients who are not eligible for voluntary consent

Primary outcome measure(s)

  • HCC detection rate — Up to 2 years
    HCC detection using each surveillance modality/Total HCC cases

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05756699 on ClinicalTrials.gov ↗ ← All trials in South Korea