Evaluation of Diagnostic Efficiency of PIVKA-II and Other Tumor Markers in HCC

Hepatocellular Carcinoma Clinical Trial

Official title: Evaluation of Diagnostic and Differential Diagnostic Significance of a Combination of PIVKA-II and Other Tumor Markers in Hepatocellular Carcinoma

Status Completed

Clinical Trial Summary

The incidence of Hepatocellular carcinoma (HCC) is increasing worldwide. However, most of HCC cases were at advanced stage when the diagnosis established.Early diagnosis improves the prognosis.The study is intended to evaluate the diagnostic efficiency of Protein Induced by Vitamin K Absence or antagonist-II(PIVKA-II). This study is a international multicenter study joined by several hospitals in China,Singapore,Thailand and Vietnam. Participants including healthy control,HCC,metastatic liver cancer,Hepatitis B virus(HBV) and liver cirrhosis are consecutively recruited into the cohort. All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II,alpha-fetoprotein and biochemical indexes including alanine aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamyl transferase(GGT),alpha-l-fucosidase(AFU),etc.

Clinical Trial Description

Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide.Early diagnosis improves the prognosis. Protein induced by vitamin K antagonist-II (PIVKA-II), also known as des-γ-carboxyprothrombin (DCP) or acarboxy prothrombin, is an abnormal form of prothrombin induced by vitamin K absence or antagonist-II. The study is intended to evaluate the diagnostic efficiency of Protein Induced by Vitamin K Absence or antagonist-II(PIVKA-II). PIVKA-II as an effective tumor marker for hepatocellular carcinoma(HCC) has been widely used in the western countries where most cases are hepatitis C virus(HCV) related.However, the majority of HCCs in China are HBV related. Despite the extensive application of PIVKA-II in some hospitals from China, the diagnostic efficiency including sensitivity,specificity,positive predictive value and negative predictive value still needs more clinical data to evaluate. The research purposes list as follows：1.Determination of diagnostic Cut-off value 2.Evaluation of diagnostic efficiency of PIVKA-II 3.Evaluation of the combination of PIVKA-II and other tumor markers for HCC. This study is an international multicenter study joined by several hospitals in China,Singapore,Thailand and Vietnam. Participants including healthy control,HCC,metastatic liver cancer,HBV and liver cirrhosis are consecutively recruited into the cohort. All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II,Alpha-fetoprotein(AFP)，alpha-fetoprotein L3 and biochemical indexes including ALT,AST,GGT,AFU,etc. The diagnosis of HCC was based on histopathology. All HCC diagnoses were confirmed at the time of analysis.The Student's t-test (or Mann-Whitney test) was used to compare continuous variables, and the chi-square test (or Fisher's exact test) was used for categorical variables. A receiver operator characteristic (ROC) curve was used to assess the performance characteristic of PIVKA-II,AFP,AFP-L3 measurement. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT03047603
• Study type: Observational
• Source: Eastern Hepatobiliary Surgery Hospital
• Status: Completed
• Start date: May 1, 2016
• Completion date: March 20, 2019