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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05756699
• Other study ID #: SNUH 2301-011-1391
• Status: Active, not recruiting
• Start date: April 10, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cirrhosis

Intervention

Diagnostic Test:
• multiple reaction monitoring (MRM)-based multimarker panel
multiple reaction monitoring (MRM)-based multimarker panel test to detect hepatocellular carcinoma

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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