Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 189
- 试验地点
- 11
- 主要终点
- Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis
研究概览
简要总结
The objective of this project is to characterize the response TRAP positive patients with Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. We plan to analyze the response TRAP over a hundred patients with various clinical stages SEP (relapsing, progressive forms) and compared to healthy controls,
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •These criteria depend on the subgroup belongs to the patient.
- •Signed consent
- •Membership of a social security system
排除标准
- •Whatever the patient group or control:
- •Processing immunosuppressive.
- •Processing by a monoclonal antibody.
- •Previous treatment with an immunosuppressant for a significant period of time (more than 6 months of oral treatment, more than 6 cycles of cyclophosphamide over 3 cures mitoxantrone).
- •Carcinomatous pathology known evolving.
- •People under guardianship.
- •Pregnant women.
- •Patients not motivated to study. Known patients with anemia (hemoglobin <10g/100ml)
研究组 & 干预措施
Control 2
Patients with central or peripheral neurological non-inflammatory, non-autoimmune.
干预措施: Trap Myelin Test (Device)
Control 3
Patients having an autoimmune pathology
干预措施: Trap Myelin Test (Device)
Relapsing Multiple Sclerosis- group 2
Multiple sclerosis defined according to the criteria of McDonald, relapsing Patient under treatment immunomodulator for at least 6 months.
干预措施: Trap Myelin Test (Device)
Relapsing Multiple Sclerosis- group 1
Definite multiple sclerosis according to the McDonald criteria, relapsing Patient innocent of thorough treatment or treatment immunomodulator stopped for at least 6 months.
干预措施: Trap Myelin Test (Device)
secondary progressive multiple sclerosis- Group 3
Multiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis
干预措施: Trap Myelin Test (Device)
primary progressive multiple sclerosis- group 4
Multiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis
干预措施: Trap Myelin Test (Device)
control 1
healthy volunteers
干预措施: Trap Myelin Test (Device)
结局指标
主要结局
Evaluate the diagnostic performance of myelin-TRAP assay for Multiple Sclerosis
时间窗: 2 years
The main criterion corresponds to the area under the curve ROC (Receiver operating characteristic). The curve ROC is a graphic representation of the existing relation between the sensibility and the specificity of a test, calculated for all the values possible thresholds. The performance of the test TRAP-myéline will thus be estimated by means of the area calculated under this curve
次要结局
- Determine the best cut-off rate of myelin-Trap and evaluate the sensitivity and specificity associated(2 years)