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临床试验/NCT06372977
NCT06372977尚未招募不适用

Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of Multiple Sclerosis and Prediction of Disease

Assiut University0 个研究点目标入组 140 人开始时间: 2024年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
主要终点
Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases .

研究概览

简要总结

To:

  1. Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases .
  2. Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis)

详细描述

Multiple sclerosis is a chronic inflammatory immune-mediated disorder of the central nervous system.Diagnosis requires the combination of clinical signs and symptoms with paraclinical findings obtained by magnetic resonance imaging and cerebrospinal fluid analysis .which are componants of the 2017 McDonald criteria .So far, the gold standard for demonstrating intrathecal IgG synthesis is represented by selective oligoclonal bands in cerebrospinal fluid by isoelectric focusing (IEF), alongside an elevated IgG index .However, the detection of oligoclonal bands in cerebrospinal fluid has several limits as , it requires a time-consuming and expensive laboratory technique, with about three hours needed to obtain results Furthermore, it only provides aqualitative information about the presence of IgG in CSF .During CNS inflammation , kappa free light chain are secreted in the CSF and their concentration reflect the degree of intrathecal B cells and plasma cells activation .Measurement of KFLC could help diagnosis of OCB negative MS and identify intrathecal immunoglobulin synthesis in patient presenting with one isolated band on isoelectric focusing , and it is fully automated,rater independent, stable against preanalytical errors . Thus, the intrathecal synthesis of free light chains are more sensitive, less costly, and less time-consuming compared To OCB detection .The most reliable parameter used to assess FLC diagnostic value in MS is the k-index, .So κ-FLC index predicted the time to conversion to MS as well as disability progression . So patients with early MS and high κ-FLC index is an independent risk factor for conversion from CIS to MS

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
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with CIS or MS according to the 2017 revision of the McDonald criteria
  • Patients diagnosed with RIS (Radiological isolated syndrome) according to the criteria by Okuda
  • Age between 18 and 40 years.

排除标准

  • History of exposure, in the 30 days prior to CSF collection, to immunosuppressant or immunomodulatory therapies .
  • Peripheral neurological disorders .
  • Infectious CNS disease.
  • CNS tumor.
  • Monoclonal gammopathy .
  • Chronic kidney injury (GFR <30 ml /min/1.75m2 )

结局指标

主要结局

Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases .

时间窗: baseline

measure specificity and sensitivity of kappa free light chain

Assess the diagnostic performance of CSF IgG OCBs in differentiating MS from other inflammatory and non-inflammatory neurological diseases .

时间窗: baseline

measure specificity and sensitivity of cerebrospinal fluid oligoclonal bands

次要结局

  • Assess the role of OCBs in predicting disease activity (conversion from CIS to MS)(baseline)
  • Assess the role of k FLC in predicting disease activity (conversion from CIS to MS)(baseline)

研究者

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

Reham mohamed ahmed abdelsater

doctor

Assiut University

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