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Epstein-Barr Virus Antibodies in Egyptian Patients With Multiple Sclerosis

2026年9月23日 更新者:Abeer Abdelbaset Mohamed Elsayed、Assiut University

Frequency and Clinical Significance of Epstein-Barr Virus Antibody Titers in Egyptian Patients With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system that causes variable degrees of neurological disability. Epstein-Barr virus (EBV) has been identified as an important environmental factor implicated in the pathogenesis and progression of MS. However, the serological profile, antibody titers, and clinical relevance of EBV infection among Egyptian individuals with MS remain limited.

The primary purpose of this hospital-based observational study is to evaluate the frequency and titers of EBV-specific antibodies, specifically anti-viral capsid antigen (anti-VCA) IgG and anti-Epstein-Barr virus nuclear antigen 1 (anti-EBNA1) IgG, in Egyptian patients diagnosed with MS compared with age- and sex-matched healthy controls. The study also aims to assess whether EBV antibody levels correlate with MS disease activity, degree of neurological disability, relapse frequency, clinical subtype, brain MRI lesion burden, and response to disease-modifying therapies (DMTs).

A total of 140 participants will be enrolled at the Department of Neurology and Psychiatry, Assiut University Hospital, comprising 70 adult patients with MS diagnosed according to the 2024 McDonald criteria and 70 matched healthy controls. Participants will undergo clinical and demographic assessment, neurological disability evaluation using the Expanded Disability Status Scale (EDSS) for MS patients, and review of existing brain MRI scans. A single venous blood sample will be collected from all participants to measure anti-VCA IgG and anti-EBNA1 IgG levels using enzyme-linked immunosorbent assay (ELISA).

研究概览

研究类型

观察性的

注册 (估计的)

140

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population comprises adult Egyptian patients aged 18 to 55 years diagnosed with multiple sclerosis who attend the Department of Neurology and Psychiatry at Assiut University Hospital (Assiut, Egypt), along with age- and sex-matched apparently healthy control individuals recruited from the same geographic region.

描述

Inclusion Criteria:

  • Adult individuals aged 18 to 55 years.
  • Confirmed diagnosis of multiple sclerosis according to the 2024 revised McDonald criteria (for the multiple sclerosis cohort).
  • Apparently healthy individuals matched by age and sex with no history of neurological disorders (for the healthy control cohort).
  • Ability to understand study procedures and provide written informed consent.

Exclusion Criteria:

  • Individuals younger than 18 years or older than 55 years.
  • Pregnancy.
  • Active or chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
  • Past or current history of malignancy.
  • Co-existing systemic immunosuppressive or autoimmune disorders unrelated to multiple sclerosis.
  • Inability or unwillingness to provide written informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:CASE_CONTROL
  • 时间观点:CROSS_SECTIONAL

队列和干预

团体/队列
Multiple Sclerosis Group

70 adult Egyptian patients aged 18-55 years diagnosed with multiple sclerosis according to the 2024 McDonald criteria. Participants will undergo clinical and neurological assessment (including Expanded Disability Status Scale [EDSS] scoring, disease duration, relapse history, and disease-modifying therapy response), review of available brain MRI scans for lesion load and distribution patterns, and venous blood sampling for serological measurement of anti-VCA IgG and anti-EBNA1 IgG antibodies using ELISA.

Healthy Control Group

70 age- and sex-matched apparently healthy individuals aged 18-55 years without history of multiple sclerosis, malignancy, viral hepatitis, HIV, or other immunosuppressive disorders. Participants will undergo demographic evaluation and venous blood sampling for serological measurement of anti-VCA IgG and anti-EBNA1 IgG antibodies using ELISA to serve as a comparison cohort.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants With Anti-VCA IgG Seropositivity
大体时间:Baseline

Assessed via enzyme-linked immunosorbent assay (ELISA) based on manufacturer-recommended optical density cut-off values to determine seropositive versus seronegative status.

Baseline
Percentage of Participants With Anti-EBNA1 IgG Seropositivity
大体时间:Baseline

Assessed via enzyme-linked immunosorbent assay (ELISA) based on manufacturer-recommended optical density cut-off values to determine seropositive versus seronegative status.

Baseline

次要结果测量

结果测量
措施说明
大体时间
Serum Anti-VCA IgG Antibody Titers
大体时间:Baseline

Quantitative or semi-quantitative antibody titer/index values of anti-viral capsid antigen (VCA) IgG determined by ELISA microplate reader optical density measurements.

Baseline
Serum Anti-EBNA1 IgG Antibody Titers
大体时间:Baseline

Quantitative or semi-quantitative antibody titer/index values of anti-Epstein-Barr virus nuclear antigen 1 (EBNA1) IgG determined by ELISA microplate reader optical density measurements.

Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2027年11月1日

研究注册日期

首次提交

2026年9月23日

首先提交符合 QC 标准的

2026年9月23日

首次发布 (实际的)

2026年9月29日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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