Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion Among Patients With or Without Lesions at the Magnetic Resonance Imaging (Oligoclonal Profile of Tears)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 30
- 主要终点
- Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
研究概览
简要总结
This is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an invasive method. Semi-automatic and automatic techniques of isoelectric focusing will be developed for analyzing data from tears. These results will help in the identification of markers of this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •18 years old or more
- •Clinically isolated syndrome of less than 3 months of onset
- •Informed consent to participate
排除标准
- •Progressive primary multiple sclerosis
- •Relapsing remitting multiple sclerosis
- •Persons wearing contact lenses
- •Ocular Infection
- •Corticoid treatment at least 30 days before sampling
- •Immunosuppressive or immunomodulatory treatment at least 3 months before sampling
- •Pregnancy or breast feeding
- •No coverage by the Social Insurance
研究组 & 干预措施
tears and cerebro-spinal fluid sampling
干预措施: tears and cerebrospinal fluid sampling (Procedure)
结局指标
主要结局
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
时间窗: two years after
Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid
次要结局
- Calculation of positive/negative predictive value(two years)
- Diagnostic performance of isoelectric focusing of tears(inclusion, two years after)
- Calculation of sensitivity/specificity(two years)
- Concordance between visual and automatic reading of electrophoretic profiles(two years)
- Calculation of efficiency odds ratio(two years)