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

Seoul National University

Status: Active, not recruiting

Conditions: Liver Cirrhosis

Treatments: Diagnostic Test: multiple reaction monitoring (MRM)-based multimarker panel

Study type: Observational

Funder types: Other

Identifiers

NCT05756699

SNUH 2301-011-1391

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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