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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Diagnostic Test: AFP-L3 and PIVKA-II in HCC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatocellular carcinoma patients<br>Serum samples are collected before liver resection. | Diagnostic Test: AFP-L3 and PIVKA-II in HCC<br>* Serum samples are tested for tumor markers including PIVKA-II, AFP, AFP-L3% and biochemical tests. Imaging: CT or MRI<br>|
| Hepatic hemangioma patients<br> | Diagnostic Test: AFP-L3 and PIVKA-II in HCC<br>* Serum samples are tested for tumor markers including PIVKA-II, AFP, AFP-L3% and biochemical tests. Imaging: CT or MRI<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, AFP-L3, PIVKA-II