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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1,418
AFP-L3 will be tested using serum sample every 6 months.
AFP will be tested using serum sample every 6 months.
PIVKA-II will be tested using serum sample every 6 months.
Sonography will be tested by experts every 6 months.
Contrast-enhanced CT will be tested annually.
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
RECRUITINGThe Catholic University of Korea Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
RECRUITINGKeimyung University Dongsan Medical Center
Daegu, South Korea
RECRUITINGInje University SangGye Paik Hospital
Seoul, South Korea
RECRUITINGKorea University Anam Hospital
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGSoonchunhyang University Seoul Hospital
Seoul, South Korea
RECRUITINGHanyang University Hospital
Seoul, South Korea
RECRUITINGKonkuk University Hospital
Seoul, South Korea
RECRUITING...and 5 more locations
HCC occurrence
Detection of HCC occurrence by three biomarkers and two image modalities
Time frame: 3 years after enrollment
Early HCC occurrence
Detection of HCC less than 2cm
Time frame: 3 years after enrollment
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