跳至主要内容
临床试验/NCT03429530
NCT03429530Unknown不适用

Study of microRNAs as a Diagnostic Tool for HCV-related Hepatocellular Carcinoma

HMHamed0 个研究点目标入组 100 人开始时间: 2018年2月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.

研究概览

简要总结

The aim of this work is to study the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.

详细描述

Early diagnosis of hepatocellular carcinoma can significantly improve the overall survival of HCC patients, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker, alpha-fetoprotein (AFP), has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC. These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. miRNAs are small endogenous, non-coding, ssRNA that are 21-30 nucleotides in length. As for the relationship between miRNA and HCC several studies have demonstrated that the aberrant expression of specific miRNA can be detected in HCC cells and tissues.

miRNAs expression profile analysis has allowed the characterization of 'identity' associated with each type of human cancer and this 'identity' is correlated with carcinogenesis, tumor progression, and response to tumor treatment.

研究设计

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

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • RNA extraction and quantitative Real-Time PCR analysis
  • Diagnosis of HCV will be based on detection of anti-HCV antibodies
  • Diagnosis of liver cirrhosis will be based on ultrasonography, biochemically and elastography when available
  • Diagnosis of HCC will be based on ultrasonography, the typical criteria in triphasic multislice CT scan

排除标准

  • HBV or autoimmune or metabolic liver disease
  • serological evidence of human immunodeficiency virus (HIV) infection
  • malignancy in other organs
  • After intervention in treatment of hepatocellular carcinoma

结局指标

主要结局

the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.

时间窗: basline

cilculating miRNAs in serum samples of HCV related HCC, HCV related liver cirrhosis , chronic HCV and healthy control group

次要结局

未报告次要终点

研究者

发起方
HMHamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

HMHamed

DR Hager

Assiut University

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