NCT04414956

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

Clinical Usefulness of Combining Biomarkers (AFP, AFP-L3, and PIVKA-II) With Abdominal Sonography or Computed Tomography for Early Detection of Hepatocellular Carcinoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,418 (estimated)
• Sponsor: Korea University · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Early diagnosis of HCC is the most important factor in improving the prognosis of the disease. A surveillance test for early diagnosis of HCC in Korea is to perform alfa fetoprotein (AFP) and abdominal sonography every 6-months in high-risk groups. However, the detection rate of HCC using AFP and abdominal sonography is very low. There are several reports that the combination of the multiple biomarker tests including AFP, AFP L3, and PIVKA-II increased the early HCC detection only one test. Therefore, in the surveillance test for HCC, the combination of three tests with sonography would be helpful in the early diagnosis of HCC. However, there was few prospective large-scale studies about this issue. Compared with abdominal sonography, contrast-enhanced CT or MRI is more useful in finding intrahepatic lesions of liver cirrhosis. However, there is no evidence data on combining sono/CT and biomarkers could improve the diagnosis for early HCC. Thus, it is essential to verify this prospectively in the real clinical practices to make recommendations based on a high level of evidence in the future. The investigators are conducting a prospective study which examines three biomarker tests and sonography every six months and contrast-enhanced CT annually for HCC surveillance in patients with cirrhosis.

Conditions

• Liver Cirrhosis
• Hepatocellular Carcinoma
• Surveillance

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2023-06-30
• Completion: 2026-02-28
• First posted: 2020-06-04
• Last updated: 2020-06-04

Locations

15 sites across 1 country: South Korea