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

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: PIVKA-II

• Registration Number: NCT03047603
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-09
• Primary Completion: 2018-09-01
• Study Completion: 2019-03-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-17
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4005

Inclusion Criteria

• Age between 18 and 85
• Receiving no treatment before diagnosis
• Establishing Diagnosis according to the Asian Pacific Association for the Study of Liver(APASL) criteria

Exclusion Criteria

• Clinical data missing
• Laboratory tests information missing
• Serum samples doesn't qualified
• Obstructive jaundice patients
• Medical history of taking warfarin

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metastatic liver cancer patients	PIVKA-II	Serum samples are collected.
Hepatocellular carcinoma patients	PIVKA-II	Serum samples are collected before liver resection.
Chronic liver disease patients	PIVKA-II	This group is comprised of liver cirrhosis and chronic hepatitis B patients. The diagnosis of liver cirrhosis are based on triple-phase contrast enhanced computed tomography, magnetic resonance imaging.
Healthy control	PIVKA-II	The healthy control group consist of people undergoing routine medical examination. Serum samples are collected.

Primary Outcome Measures

Name	Time	Method
PIVKA-II	Day one	Using PIVKA-II assay kit(chemiluminescent microparticle immunoassay).

Secondary Outcome Measures

Name	Time	Method
ALT, AST，γ-GT， AFU	Day one
AFP,AFP-L3%	Day one

Trial Locations

Locations (1)

Eastern hepatobiliary surgery hospital; 🇨🇳 Shanghai, Shanghai, China