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临床试验/NCT06060275
NCT06060275尚未招募不适用

Neurofilament Light Chain as a Potential Marker in Behcet's Disease

Assiut University0 个研究点目标入组 60 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
aim at our study to assess the role of NFL chain in serum of behcet disease in those with and without peripheral and central nervous system affection and its relation to neurological manifestation

研究概览

简要总结

To determine the role of neurofilament light chain in Behçet's disease with or without neurological affection and its relation to neurological manifestation (either peripheral or central ).

详细描述

Behçet disease is a multisystemic autoinflammatory disorder characterized by recurrent oral and genital ulcer, eye affection, thrombosis and many systems can be affected with the most serious being the nervous system affection which is commonly called neuro-Behçet's disease (NBD) In Ghita et al, the prevalence of Behcet disease in Egypt was estimated to be 3.6/100,000 with CNS affection occurred in about 13.1% of the patients , while in other study performed in Egypt the peripheral neuropathy affection reached 53.3% of the patients with insignificant difference between both upper and lower limb but sensory affection was manifested more than motor affection in those patients.

Neurofilament light chain (NFL) is a neuronal cytoplasmic protein, which was assumed to have a role as a prognostic biomarker in several neuroimmunological and neurodegenerative diseases. It was documented in peripheral nerve affection of patients with diabetes mellitus and GuillainBarré syndrome. Recently, some studies documented the presence of high level of NFL chain in serum of neurolupus and primary sjogren's diseases , more over in 2022, Karaaslan et al. measured NFL in the cerebrospinal fluid (CSF) and found it high in neurobehcet patients and assumed that it can predict the prospective cognitive and somatic disability in NBD patients.

So, the investigators aim at our study to assess the role of NFL chain in serum of behcet disease in those with and without peripheral and central nervous system affection and its relation to neurological manifestation.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • any adult patient satisfied International study group criteria of Behcet's disease

排除标准

  • Patients with definite diagnosis for any other causes affecting central and peripheral nervous system eg....
  • Infection (Viral, Bacterial, Fungal)
  • Drug induced
  • Other diseases (Multiple sclerosis, Neuromyelitis Optica)
  • other autoimmune diseases
  • Diabetic patients
  • purely degenerative diseases

结局指标

主要结局

aim at our study to assess the role of NFL chain in serum of behcet disease in those with and without peripheral and central nervous system affection and its relation to neurological manifestation

时间窗: baseline

compare the level of NFL in serum between groups of Behcet patients with or without central and peripheral Nervous system affection

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

Nayera Ahmed Abdelhamed

Nayera Ahmed Abdelhamed

Assiut University

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