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

February 17, 2024 updated by: Tian Yang, Eastern Hepatobiliary Surgery Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4005

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern Hepatobiliary Surgery Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The participants will be recruited through outpatient clinics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatocellular carcinoma patients
Serum samples are collected before liver resection.
Diagnostic test: PIVKA-II
Serum samples are tested for tumor markers including PIVKA-II,AFP,AFP-L3% and biochemical tests.
Other Names:
  • DCP
Healthy control
The healthy control group consist of people undergoing routine medical examination. Serum samples are collected.
Diagnostic test: PIVKA-II
Serum samples are tested for tumor markers including PIVKA-II,AFP,AFP-L3% and biochemical tests.
Other Names:
  • DCP
Metastatic liver cancer patients
Serum samples are collected.
Diagnostic test: PIVKA-II
Serum samples are tested for tumor markers including PIVKA-II,AFP,AFP-L3% and biochemical tests.
Other Names:
  • DCP
Chronic liver disease patients
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.
Diagnostic test: PIVKA-II
Serum samples are tested for tumor markers including PIVKA-II,AFP,AFP-L3% and biochemical tests.
Other Names:
  • DCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PIVKA-II
Time Frame: Day one
Using PIVKA-II assay kit(chemiluminescent microparticle immunoassay).
Day one

Secondary Outcome Measures

Outcome Measure
Time Frame
AFP,AFP-L3%
Time Frame: Day one
Day one
ALT, AST，γ-GT， AFU
Time Frame: Day one
Day one

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Collaborators

Peking University First Hospital
Sun Yat-sen University
RenJi Hospital
First Affiliated Hospital Xi'an Jiaotong University
Gansu Provincial Hospital
The First Hospital of Jilin University
Henan Provincial People's Hospital
Sichuan Provincial People's Hospital
Abbott Diagnostics Division

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

March 20, 2019

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Estimated)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pivkaii

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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