Diagnostic Value of AFP-L3 and PIVKA-II in HCC

March 2, 2018 updated by: Bui My Hanh, Hanoi Medical University
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 alpha-fetoprotein-L3 (AFP-L3) and Protein Induced by Vitamin K Absence or antagonist-II (PIVKA-II). This study is performed at Hanoi Medical University Hospital. Participants including patients with HCC and hepatic hemangioma. 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, AFP, AFP-L3 and biochemical indexes including alanine aminotransferase(ALT),aspartate aminotransferase (AST), gamma-glutamyl transferase, HbsAg, Anti HCV, etc.

Study Overview

Status

Unknown

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 AFP-L3 and PIVKA-II. AFP-L3 and PIVKA-II as an effective tumor marker for hepatocellular carcinoma(HCC). Despite the extensive application of PIVKA-II in some hospitals from Vietnam, 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 changes in AFP-L3 and PIVKA II for HCC.2. Investigating the diagnostic value of AFP-L3 and PIVKA II for HCC. This study is performed at Hanoi Medical University Hospital. Participants including patients with HCC and hepatic hemangioma. 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, AFP, AFP-L3 and biochemical indexes including alanine aminotransferase(ALT),aspartate aminotransferase (AST), gamma-glutamyl transferase, HbsAg, Anti HCV, etc.The diagnosis of HCC was based on HCC criteria of Ministry of Public Health of Vietnam. All HCC diagnoses were confirmed at the time of analysis. Stages of tumor is evaluated by Barcelana classification. 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 (Anticipated)

200

Contacts and Locations

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

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 100000
        • Recruiting
        • Hanoi Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tran Ngoc Anh, MD
        • Sub-Investigator:
          • Duong Mai Chi, MD

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The participants will be recruited through outpatient clinics and inpatient in Hanoi Medical University Hospital.

Description

Inclusion Criteria:

  • Age between 18 and 85
  • Receiving no treatment before diagnosis
  • Establishing Diagnosis according to thecriteria of Ministry of Public Health of Vietnam 2012.

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: Case-Crossover
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatocellular carcinoma patients
Serum samples are collected before liver resection.
Diagnostic test: AFP-L3 and PIVKA-II in HCC

Serum samples are tested for tumor markers including PIVKA-II, AFP, AFP-L3% and biochemical tests.

Imaging: CT or MRI
Hepatic hemangioma patients
Diagnostic test: AFP-L3 and PIVKA-II in HCC

Serum samples are tested for tumor markers including PIVKA-II, AFP, AFP-L3% and biochemical tests.

Imaging: CT or MRI

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
Measure Description
Time Frame
Alpha-Fetoprotein (AFP)
Time Frame: Day one
Using chemiluminescent microparticle immunoassay to measure AFP levels
Day one
Alpha-Fetoprotein-L3% (AFP-L3%)
Time Frame: Day one
Using µTASWako i30 automated immunoassay analyzer to measure AFP-L3% levels
Day one
Alanine Aminotransferase (ALT)
Time Frame: Day one
Using Abbott Architect automated immunoassay analyzer to measure ALT levels
Day one
Aspartate Aminotransferase (AST)
Time Frame: Day one
Using Abbott Architect automated immunoassay analyzer to measure AST levels
Day one
Gamma Glutamyl Transferase (γ-GT)
Time Frame: Day one
Using Abbott Architect automated immunoassay analyzer to measure γ-GT levels
Day one
Hepatitis B virus surface antigen (HBsAg)
Time Frame: Day one
Using Abbott Architect automated immuno-analyzer to measure HBsAg levels
Day one
Antibodies to Hepatitis C virus (Anti HCV)
Time Frame: Day one
Using Abbott Architect automated immunoassay analyzer to measure Anti HCV levels
Day one
Albumin
Time Frame: Day one
Using Abbott Architect automated immunoassay analyzer to measure Albumin levels
Day one
Prothrombin Time (PT) (%)
Time Frame: Day one
Using Abbott Architect automated immunoassay analyzer to measure PT (%)
Day one

Collaborators and Investigators

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

Sponsor

Hanoi Medical University

Collaborators

Bach Mai Hospital

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)

January 1, 2018

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMU16222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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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