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临床试验/NCT03460080
NCT03460080已完成不适用

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

Hanoi Medical University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

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

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

发起方
Hanoi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bui My Hanh

Director, Science Research and International Cooperation Unit

Hanoi Medical University

研究点 (2)

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