Diagnostic Value of AFP-L3 and PIVKA-II in HCC
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Diagnostic Test: AFP-L3 and PIVKA-II in HCC
- Registration Number
- NCT03460080
- Lead Sponsor
- Hanoi Medical University
- 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 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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Age between 18 and 85
- Receiving no treatment before diagnosis
- Establishing Diagnosis according to thecriteria of Ministry of Public Health of Vietnam 2012.
- 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 Hepatic hemangioma patients AFP-L3 and PIVKA-II in HCC - Hepatocellular carcinoma patients AFP-L3 and PIVKA-II in HCC Serum samples are collected before liver resection.
- Primary Outcome Measures
Name Time Method PIVKA-II Day one Using PIVKA-II assay kit (chemiluminescent microparticle immunoassay)
- Secondary Outcome Measures
Name Time Method Antibodies to Hepatitis C virus (Anti HCV) Day one Using Abbott Architect automated immunoassay analyzer to measure Anti HCV levels
Alpha-Fetoprotein-L3% (AFP-L3%) Day one Using µTASWako i30 automated immunoassay analyzer to measure AFP-L3% levels
Prothrombin Time (PT) (%) Day one Using Abbott Architect automated immunoassay analyzer to measure PT (%)
Alpha-Fetoprotein (AFP) Day one Using chemiluminescent microparticle immunoassay to measure AFP levels
Gamma Glutamyl Transferase (γ-GT) Day one Using Abbott Architect automated immunoassay analyzer to measure γ-GT levels
Albumin Day one Using Abbott Architect automated immunoassay analyzer to measure Albumin levels
Alanine Aminotransferase (ALT) Day one Using Abbott Architect automated immunoassay analyzer to measure ALT levels
Aspartate Aminotransferase (AST) Day one Using Abbott Architect automated immunoassay analyzer to measure AST levels
Hepatitis B virus surface antigen (HBsAg) Day one Using Abbott Architect automated immuno-analyzer to measure HBsAg levels
Trial Locations
- Locations (1)
Hanoi Medical University
🇻🇳Hanoi, Vietnam