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