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临床试验/NCT03893344
NCT03893344已完成不适用

Detection of STAT4 in Multiple Sclerotic Patients by Polymerase Chain Reaction and Flow Cytometry

Assiut University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2019年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
1
主要终点
To determine the level of STAT4 expression in different cases of multiple sclerosis

研究概览

简要总结

  1. To determine the level of STAT4 expression in different cases of multiple sclerosis and its relation to disease severity .
  2. compare the sensitivity and specificity of STAT4 levels using both PCR and flow cytometry.

详细描述

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating and neurodegenerative disease of the central nervous system (CNS) (Huang et al., 2017).

The exact etiology of the disease is unknown, it is a heterogeneous, multifactorial and immune-mediated disease that is caused by complex gene-environment interactions (Olsson el al., 2017). It is mediated by autoreactive lymphocytes that cross the blood brain barrier (BBB) and enter the CNS where they cause local inflammation that results in demyelination, gliotic scarring, and axonal loss (Huang et al., 2017).

The onset of MS has been typically observed in individuals aged from 20 to 40 years, with the female to male ratio of 2:1 (Koch-Henriksen and Sørensen, 2010). According to a documented MS registry from Egypt done in 2010 and 2017, the epidemiology of MS was slightly differed from other Arab countries and western countries. The mean age of disease onset was 26.6±7.8 years, with the majority being females (2.11:1). Relapsing-remitting MS was the most common type (75.1%) (Hamdy et al., 2017). And its prevalence was found to be 14.1/100.000 (Hashem et al., 2010).

The pathological hallmark of MS is the accumulation of inflammatory demyelinating lesions that occur in the white matter and the grey matter of the brain and spinal cord (Celius and Smestad, 2009).

MS is regarded as a T cell mediated autoim¬mune disorder with a predominance of CD8+ cells compared with other T-cell subsets. The disease begins in inflammatory induced lesions consisting mainly of CD8+ T cells, and CD4+ T cells, and activate microglia/macrophages (Traugott et al., 1983; Ferguson el al., 1997). B lymphocytes and their cytokines are other factors in the pathogenesis of the disease. They have both positive and negative effects in the development of MS through lymphotoxin and IL-10, respectively (Duddy el al., 2007). It can be triggered by various environmental components, such as exposure to ultraviolet light, drugs, chemicals, and viral infections (Olsson el al., 2017).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • The diagnosis of MS patients will be established clinically from the history according to revised McDonald's criteria 2010.

排除标准

  • Patients proved not to have MS either at first interview or at any time during follow up or with other autoimmune diseases will be ruled out of the study.
  • Healthy group with past or present medical history of autoimmune disease or other neurologic condition.

结局指标

主要结局

To determine the level of STAT4 expression in different cases of multiple sclerosis

时间窗: baseline

measuring the level of STAT4 gene in both the control group and different cases of multiple sclerotic and its relation to disease pathogenesis and severity

次要结局

  • compare the sensitivity and specificity of STAT4 levels using both PCR and flow cytometry.(baseline)

研究者

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

Mai Mohammed SalahElDin

Assistant Lecturer at Assiut University

Assiut University

研究点 (1)

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