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Completed

NCT Number: NCT03460080

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanoi Medical University

Hanoi, 100000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AFP-L3 and PIVKA-II in HCC

Diagnostic Test

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

Imaging: CT or MRI

Primary outcomes

  1. PIVKA-II

    Time frame: Day one

    Using PIVKA-II assay kit (chemiluminescent microparticle immunoassay)

Secondary outcomes

  1. Alpha-Fetoprotein (AFP)

    Time frame: Day one

    Using chemiluminescent microparticle immunoassay to measure AFP levels

  2. Alpha-Fetoprotein-L3% (AFP-L3%)

    Time frame: Day one

    Using µTASWako i30 automated immunoassay analyzer to measure AFP-L3% levels

  3. Alanine Aminotransferase (ALT)

    Time frame: Day one

    Using Abbott Architect automated immunoassay analyzer to measure ALT levels

  4. Aspartate Aminotransferase (AST)

    Time frame: Day one

    Using Abbott Architect automated immunoassay analyzer to measure AST levels

  5. Gamma Glutamyl Transferase (γ-GT)

    Time frame: Day one

    Using Abbott Architect automated immunoassay analyzer to measure γ-GT levels

  6. Hepatitis B virus surface antigen (HBsAg)

    Time frame: Day one

    Using Abbott Architect automated immuno-analyzer to measure HBsAg levels

  7. Antibodies to Hepatitis C virus (Anti HCV)

    Time frame: Day one

    Using Abbott Architect automated immunoassay analyzer to measure Anti HCV levels

  8. Albumin

    Time frame: Day one

    Using Abbott Architect automated immunoassay analyzer to measure Albumin levels

  9. Prothrombin Time (PT) (%)

    Time frame: Day one

    Using Abbott Architect automated immunoassay analyzer to measure PT (%)

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Collaborators

  • Bach Mai Hospital

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2018
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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