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

NCT05756699 | Active Not Recruiting

• 1 other identifier: SNUH 2301-011-1391
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• HCC detection rate

  HCC detection using each surveillance modality/Total HCC cases

  Up to 2 years

Secondary Outcomes (3)

• Early HCC detection rate

  Up to 2 years

• False referral rate

  Up to 2 years

• Positive predictive value

  Up to 2 years

Interventions

multiple reaction monitoring (MRM)-based multimarker panel DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

After obtaining informed consent, a total of 40 cc of blood will be obtained from patients (20 cc x 2 times).

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 6, 2023
• Study Start: April 10, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

KR (1)