Identification of Multiple Sclerosis Biomarkers in Human CSF by Means of Cytokine Array
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Identification of SEP markers
研究概览
简要总结
Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Brain MRI is very useful for MS diagnosis but prognostic biomarkers are still needed. New therapies are also expected to improve MS care. Cytokine arrays provide measure of many different inflammation-related molecules that could help understanding the disease. Moreover, individual prognosis could be linked with the level of such molecules in the CSF of MS patients. The investigators will analyze the cytokine profile of MS and control patients CSF to determine a specific profile of MS and look for prognosis implication in a cohort of patients with clinically isolated syndromes (first manifesatation of MS).
详细描述
Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Early treatment could allow better prognosis for the patients in the long term by reducing relapses rates and neurological palsy. However, individual prognostic biomarkers are still needed to adapt the treatment to a given patient. CSF is a strategic body fluid to explore in neurological diseases. In MS, it contains an elevated IgG index and/or oligoclonal bands reflecting the intrathecal synthesis of Igs around the brain. The levels of other inflammatory molecules such cytokines and metalloproteases are also known to be elevated in MS (GM-CSF, IL-6, IL-10, MMP-2, MMP9, TIMP-1, TNF-α, RANTES, MCP-1 and MIP-1). These molecules can now be easily measured by protein arrays.The aim of this study is to measure the level of 40 cytokines and 10 MMPs by means of protein arrays in the CSF from clinically definite MS (CDMS) patients, control patients and patients with a clinically isolated syndrome (CIS). The best MS markers will be determined using multiple ROC curves. Markers of rapid conversion to CDMS after a CIS will also be looked for.The best MS candidate biomarkers will be analyzed by ELISA in a new cohort of patients being recruited.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically definite Multiple sclerosis patients (at least 2 relapses)
- •Patient having presented another neurological episode suggestive of MULTIPLE SCLEROSIS confirmed or not by a neurologist and allowing to establish the diagnosis of MULTIPLE SCLEROSIS according to the criteria of Mc Donald
- •Age ≥ 18 years
- •Patients informed about the objectives of the study and about its practical realization
排除标准
- •Patient having received a treatment by corticoids in 30 days before the lumbar puncture
- •Contraindication of the lumbar puncture such as an anticoagulating oral treatment for example
- •Pregnancy
结局指标
主要结局
Identification of SEP markers
时间窗: 24 months
The aim of this study is to measure the level of 40 cytokines and 10 MMPs by means of protein arrays in the CSF from clinically definite MS (CDMS) patients, control patients and patients with a clinically isolated syndrome (CIS). The best MS markers will be determined using multiple ROC curves.
次要结局
未报告次要终点