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

STATUS

Recruiting
End date

Feb 28, 2026
participants needed

1418
sponsor

Korea University

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Updated on 19 February 2024

See if I qualify

cancer

stiffness

ct scan

fibrosis

warfarin

liver transplant

early diagnosis

thrombocytopenia

carcinoma

cirrhosis

encephalopathy

ascites

jaundice

hepatocellular carcinoma

hypoalbuminemia

early detection

varicose veins

hepatic decompensation

gastric varices

pivka-ii

apri

des-gamma-carboxy prothrombin

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.

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.

Details

Condition	Adenocarcinoma, Adenocarcinoma, Cirrhosis, LIVER DISEASE, LIVER DISEASE, HEPATIC NEOPLASM, liver cancer, HEPATOCELLULAR CARCINOMA, Frequency, liver cancer
Age	19years - 75years
Treatment	AFP-L3, AFP, PIVKA-II, Sonography, CT
Clinical Study Identifier	NCT04414956
Sponsor	Korea University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients with liver cirrhosis meeting one of the followings: i. Histologically confirmed liver cirrhosis ii. Imaging findings with liver cirrhosis (liver surface undulation, irregularity, or nodularity by US, CT, or MRI) plus one of followings: liver stiffness measurement 12.5 kilopascal, esophago-gastric varices, thrombocytopenia (<120,000/mm3), hypoalbuminemia (<3.5 g/dL), splenomegaly 12 cm) iii. Imaging findings with liver cirrhosis together with biomarkers suggesting liver cirrhosis (APRI 2.0 or fibrosis-4 3.6) iv. Imaging findings with liver cirrhosis with history of hepatic decompensation (ascites, esophago-gastric variceal bleeding, jaundice, hepatic encephalopathy))
	Expected survival more than 1 year
	Child Pugh score 5-10 at the time of enrollment
	Serum creatinine 1.5mg/dL
	Age between 19 and 75 years old
	No significant underlying medical illness affecting patient's survival
	Patients available for regular follow-up according to the study protocol
Exclusion Criteria
	History of HCC
	AFP >20 ng/mL
	Hepatic nodule 1 cm by US or CT Exceptionally, nodules showing characteristic features of benign lesion such as hemangioma or pathologically conformed benign lesion are permitted for study inclusion
	Hepatic nodule less than 1 cm on US but imaging findings suggesting HCC by contrast enhanced US, CT, or MRI
	Child-Pugh score 11
	History of liver transplantation
	Expecting liver transplantation within 1 year
	Hypersensitivity on CT contrast dye
	Any contraindication for CT
	Not able to perform abdominal US
	Other uncontrolled malignancy
	Patients taking warfarin

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