跳至主要内容
临床试验/NCT02541149
NCT02541149已完成不适用

Evaluation of Annexin A2 as a Novel Diagnostic Marker for Hepatocellular Carcinoma in Egyptian Patients

Ain Shams University0 个研究点目标入组 90 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
serum Annexin A2 in patients with hepatocellular carcinoma, chronic liver disease and healthy subjects

研究概览

简要总结

This study aimed to investigate the clinical utility of Annexin A2 serum level as a novel diagnostic marker of hepatocellular carcinoma (HCC) and to correlate its level with alpha fetoprotein the current marker ofhepatocellular carcinoma (HCC).

详细描述

This study was carried out in HCC clinic , Ain Shams University Hospitals, Cairo; Egypt and included :Group 1: Fifty patients with early stage hepatocellular carcinoma(BCLC stage A); Group 2:Twenty five patients with chronic liver disease diagnosed based on clinical, laboratory, and ultrasonographic investigations; Control Group: Fifteen healthy, age and sex-matched subjects with seronegative hepatitis viral markers .All groups were subjected to thorough history taking, full clinical examination, and laboratory investigations including viral hepatitis markers: HBsAg and HCV antibodies using ELISA technique and HCV RNA using real time PCR for HCV antibody positive patients, AFP by electrochemiluminescence and Annexin A2 estimation using ELISA technique.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for HCC cases:
  • Confirmed diagnosis of HCC according to the European association of study of liver diseases [13].
  • Early stage HCC (Stage A), using the Barcelona Clinic Liver Cancer (BCLC) staging system, (single or 3 nodules < 3cm PS 0) For all participants:.
  • Informed consent from all participants before enrollment in the study.

排除标准

  • For HCC patients:
  • 1-Imtermediate or advanced stage HCC as defined by BCLC
  • Major vascular tumor invasion or metastasis confirmed by radiological imaging studies.
  • Patients with other suspected solid malignancies or metastatic liver tumors,
  • Other types of chronic liver diseases (CLD) such as autoimmune hepatitis and primary biliary cirrhosis.
  • For all participants:
  • Refusal to participate in the study

结局指标

主要结局

serum Annexin A2 in patients with hepatocellular carcinoma, chronic liver disease and healthy subjects

时间窗: 1 month

to determine the clinical utility of Annexin A2 serum level as a novel diagnostic marker of hepatocellular carcinoma (HCC) and to correlate its level with alpha fetoprotein the current marker of (HCC).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Iman Fawzy Montasser

Lecturer of tropical medicine , Ain Shams university

Ain Shams University

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