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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05756699

Enrollment

200

Registered

2023-03-06

Start date

2023-04-10

Completion date

2026-12-31

Last updated

2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

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.

Interventions

DIAGNOSTIC_TESTmultiple reaction monitoring (MRM)-based multimarker panel

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026