Diagnosic and Pronostic Values of Kappa and Lambda Free Light Chains in Central Nervous System Inflammatory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 14
- 主要终点
- Measurement of cerebrospinal fluid (CSF) and serum kappa and lambda free light chains (KFLC and LFLC)
研究概览
简要总结
Numerous studies have shown the diagnostic interest of cerebrospinal fluid kappa free light chains and kappa index in multiple sclerosis. However, large cohort studies are lacking and little is known about the correlation between kappa and lambda indexes and multiple sclerosis evidence disease activity. Therefore, this study plan to validate the kappa and lambda free light chains and indexes as diagnostic biomarker in multiple sclerosis and to correlate the concentration of kappa and lambda free light chains with clinical and radiological activity in a large cohort of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with symptoms evocative of CNS involvement for who serum and cerebrospinal fluid kappa free light chains and kappa index are available
排除标准
- •Infectious CNS disease
- •Tumor CNS disease
- •Active CNS bleeding
- •Monoclonal gammapathy
- •Severe chronic renal failure (glomerular filtration rate <30 ml/mn)
结局指标
主要结局
Measurement of cerebrospinal fluid (CSF) and serum kappa and lambda free light chains (KFLC and LFLC)
时间窗: 1 day
1. Measurement of cerebrospinal fluid (CSF) and serum KFLC and LFLC by a turbilimetric analyzer (data in mg/L) 2. Quantification of QKFLC and QLFLC (CSF FLC/serum FLC) in each group of patients 3. Compare median of QKFLC and QLFLC between groups
Measurement of cerebrospinal fluid (CSF) and serum albumin
时间窗: 1 day
1. Measurement of cerebrospinal fluid (CSF) and serum albumin by the same turbilimetric analyzer (data in mg/L) 2. Quantification of albumin quotient (AQ) (CSF albumin/serum albumin) in each group of patients
Evaluation of the diagnostic performances of KFLC and LFLC intrathecal synthesis biomarkers (K/L FLC index and K/L FLC intrathecal fraction (IF)) for multiple sclerosis
时间窗: 1 day
1. Calculation of KFLC intrathecal synthesis biomarkers: KFLC index = (CSF KFLC/serum KFLC) / AQ KFLC IF = (KFLC(loc)/CSF KFLC) x 100 with: KFLC(loc) = ((CSF KFLC/serum KFLC) / Qk(lim)) x serum KFLC and Qk(lim) = 3.27 x (AQ\^2 + 33)\^0.5 - 8.2 2. Calculation of LFLC intrathecal synthesis biomarkers: LFLC index = (CSF LFLC/serum LFLC) / AQ) LFLC IF = (LFLC(loc)/CSF LFLC) x 100 with: LFLC(loc) = ((CSF LFLC/serum LFLC) / Ql(lim)) x serum LFLC and Ql(lim) = 2.1138 x AQ\^0.865 3. Determination of diagnostic performances by ROC curve analysis and best cut-off values with the Younden index to calculate sensitivity, specificity and predictive values for MS diagnosis
Comparison of diagnostic performances of K/L FLC intrathecal synthesis biomarkers to oligoclonal bands (OCB) for multiple sclerosis
时间窗: 1 day
1. Identification of OCB status for each patient 2. Calculation of diagnostic performances of OCB (sensitivity, specificity and predictive values) for MS diagnostic 3. Comparison of diagnostic performances (sensitivity, specificity and predictive values) of OCB and K/L FLC intrathecal synthesis biomarkers for multiple sclerosis
次要结局
- Evaluation of clinical data that can alter KFLC and LFLC values(1 day)