NCT07304960尚未招募不适用
Comparative Study Between Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder Patients in Assiut Hospitals Clinical and Laboratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- serum Glial Fibrillary Acidic Protein levels
研究概览
简要总结
The aim of this work is to do a detailed comparison between multiple sclerosis and Neuromyelitis Optica Spectrum Disorder due to delicate similarities between both diseases and wide rang of management and follow up of the patients
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Both sex 2- Aged between 18 and 50 years. All included patients were in a clinically stable phase and had not experienced a relapse within at least three months before blood sampling. 3- All patients diagnosed as MS patients either naive or on disease modifying therapies according to The new diagnostic criteria MacDonalds 2024 4- DMT-naïve NMOSD patients: Diagnosed with MS based on the 2017 McDonald Criteria (Thompson et al., 2018)
- •5- An informed consent will be obtained from all the patients; the study will be approved by ethical committee in faculty of Medicine Assiut University
- •1_ Presence of other disorder that mimic MS or NMOSD 3_ Patients failed to commit to the follow up visits and regular MRI scans 4_ Patients refused to sign the written informed consent
排除标准
- •1_ Presence of other disorder that mimic MS or NMOSD 3_ Patients failed to commit to the follow up visits and regular MRI scans 4_ Patients refused to sign the written informed consent
结局指标
主要结局
serum Glial Fibrillary Acidic Protein levels
时间窗: Baseline
Measurement of serum concentrations of Glial Fibrillary Acidic Protein at baseline using a validated immunoassay (e.g., single-molecule array \[Simoa\] assay). difference in serum Glial Fibrillary Acidic Protein levels between treatment-naïve NMOSD and treatment-naïve MS patientsexpressed in picograms per milliliter (pg/mL).
次要结局
- Correlation between serum biomarkers (sGFAP and sNfL) and lesion burden on MRI.(Baseline)
- Correlation between serum biomarkers (sGFAP and sNfL) and Expanded Disability Status Scale (EDSS).(Baseline)
- Association between serum biomarkers and optic nerve involvement (length and presence of LETM).(Baseline)
- Diagnostic performance of sGFAP and combined sGFAP + sNfL in differentiating NMOSD from MS.(Baseline)
研究者
Hussein Abd Elrahim Hussein Mohamed
Resident doctor
Assiut University
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