Combining Biomarkers (AFP, AFP-L3, and PIVKA-II) and Image Tools for Early Detection of Hepatocellular Carcinoma

Summary

In this study, three biomarkers tests (AFP, AFP-L3 and PIVKA-II) and abdominal sonography or CT scans are performed every 6 months to detect hepatocellular carcinoma (HCC) early in patients with cirrhosis, a high-risk group of HCC. The aim of this study is to confirm the early HCC diagnosis rate in patients with cirrhosis and compare the detection efficacy between tests.

Conditions

• Liver Cirrhosis
• Hepatocellular Carcinoma
• Surveillance

Interventions

DIAGNOSTIC_TEST

AFP-L3

AFP-L3 will be tested using serum sample every 6 months.

DIAGNOSTIC_TEST

AFP

AFP will be tested using serum sample every 6 months.

DIAGNOSTIC_TEST

PIVKA-II

PIVKA-II will be tested using serum sample every 6 months.

DIAGNOSTIC_TEST

Sonography

Sonography will be tested by experts every 6 months.

DIAGNOSTIC_TEST

CT

Contrast-enhanced CT will be tested annually.

Sponsors & Collaborators

• Korea University Ansan Hospital

  collaborator OTHER

• Soonchunhyang University Hospital

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Korea University Anam Hospital

  collaborator OTHER

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Hanyang University

  collaborator OTHER

• Konkuk University Hospital

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Inje University

  collaborator OTHER

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  collaborator OTHER

• Korea University

  lead OTHER

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-01

Primary Completion

2023-06-30

Completion

2026-02-28

Countries

• South Korea

Study Locations