Diagnostic Value of AFP-L3 and PIVKA-II in HCC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- PIVKA-II
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85
- •Receiving no treatment before diagnosis
- •Establishing Diagnosis according to thecriteria of Ministry of Public Health of Vietnam 2012.
排除标准
- •Clinical data missing
- •Laboratory tests information missing
- •Serum samples doesn't qualified
- •Obstructive jaundice patients
- •Medical history of taking warfarin
研究组 & 干预措施
Hepatocellular carcinoma patients
Serum samples are collected before liver resection.
干预措施: AFP-L3 and PIVKA-II in HCC (Diagnostic Test)
Hepatic hemangioma patients
干预措施: AFP-L3 and PIVKA-II in HCC (Diagnostic Test)
结局指标
主要结局
PIVKA-II
时间窗: Day one
Using PIVKA-II assay kit (chemiluminescent microparticle immunoassay)
次要结局
- Antibodies to Hepatitis C virus (Anti HCV)(Day one)
- Alpha-Fetoprotein-L3% (AFP-L3%)(Day one)
- Prothrombin Time (PT) (%)(Day one)
- Alpha-Fetoprotein (AFP)(Day one)
- Gamma Glutamyl Transferase (γ-GT)(Day one)
- Albumin(Day one)
- Alanine Aminotransferase (ALT)(Day one)
- Aspartate Aminotransferase (AST)(Day one)
- Hepatitis B virus surface antigen (HBsAg)(Day one)
研究者
Bui My Hanh
Director, Science Research and International Cooperation Unit
Hanoi Medical University
