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| Name | Class |
|---|---|
| Bach Mai Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatocellular carcinoma patients | Serum samples are collected before liver resection. |
| |
| Hepatic hemangioma patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| PIVKA-II | Using PIVKA-II assay kit (chemiluminescent microparticle immunoassay) | Day one |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The participants will be recruited through outpatient clinics and inpatient in Hanoi Medical University Hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi Medical University | Recruiting | Hanoi | 100000 | Vietnam |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 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 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |