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

Active, not recruiting

• Conditions: Liver Cirrhosis

• Registration Number: NCT05756699
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-06
• Study Start: 2023-04-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HCC detection rate	Up to 2 years	HCC detection using each surveillance modality/Total HCC cases

Secondary Outcome Measures

Name	Time	Method
Early HCC detection rate	Up to 2 years	Early HCC (BCLC stage 0 or 1) detection using each surveillance modality/Total early HCC cases
False referral rate	Up to 2 years	False-positive case of each surveillance modality/Total false-positive and false-negative results
Positive predictive value	Up to 2 years	True-positive case of each surveillance modality/Total positive cases

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of