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

A Prospective Study Evaluating the Accuracy of Proteome Multimarker Panel With Multiple Reaction Monitoring vs. Ultrasonography and Serum AFP as a Surveillance for Hepatocellular Carcinoma in High-Risk Population

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Diagnostic test: multiple reaction monitoring (MRM)-based multimarker panel

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with liver cirrhosis who receive regular surveillance for hepatocellular carcinoma.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCC detection rate	HCC detection using each surveillance modality/Total HCC cases	Up to 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Fibrosis; Carcinoma, Hepatocellular; Liver Cirrhosis
• Other Study ID Numbers: SNUH 2301-011-1391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No