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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Diagnostic Test: multiple reaction monitoring (MRM)-based multimarker panel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: multiple reaction monitoring (MRM)-based multimarker panel|multiple reaction monitoring (MRM)-based multimarker panel test to detect hepatocellular carcinoma|

What is the study measuring?
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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 |