NCT03981003招募中不适用
Serum Neurofilament-light Chain and Glial Fibrillary Acidic Proten (GFAP) Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis
Centre Hospitalier Universitaire de Nīmes28 个研究点 分布在 2 个国家目标入组 1,150 人开始时间: 2019年5月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,150
- 试验地点
- 28
- 主要终点
- GFAP level in patients with evolving disease compared to those with stable disease
研究概览
简要总结
The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease.
In addition, Glial Fibrillary Acidic Protein (GFAP) has also been identified as another serum biomarker of disability in MS.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has been correctly informed.
- •The patient must have given their informed and signed consent.
- •The patient must be insured or beneficiary of a health insurance plan.
- •The patient is at least (≥)15 years old.
- •The patient has MS according to diagnosis criteria (Thompson et al. 2017) and:
- •Participates to the OFSEP-HD cohort (ancillary study);
- •Has a Expanded Disability Status Scale score comprised between 0 - 7.0;
- •With or without Disease Modifying Drug;
- •For Work Package 3: patients enrolled in any OFSEP-HD centre that meet landmark criteria for an active MS (relapse, or Expanded Disability Status Scale progression, or active MRI) during follow-up;
- •For Work Package 4: patients with a stable disease enrolled in OFSEP-HD study in Nîmes or Nantes University Hospitals.
排除标准
- •Within the past three months, the patient has participated in another interventional study that may interfere with the results or conclusions of this study.
- •The patient is in an exclusion period determined by a previous study.
- •The patient is under judicial protection.
- •The patient refuses to sign the consent.
- •It is impossible to correctly inform the patient (inability to understand the study, language problem).
- •The patient is pregnant or breast-feeding.
- •The patient is under 15 years old.
- •Inability to answer questionnaires.
- •Clinically isolated syndrome (CIS) that does not meet the criteria of MS.
- •Radiologically isolated syndrome (RIS).
- •Patient with Neuromyelitis optica spectrum disorder.
结局指标
主要结局
GFAP level in patients with evolving disease compared to those with stable disease
时间窗: 6 years
pg/mL; measured by digital ELISA
Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease
时间窗: 2 years
pg/mL; measured by digital ELISA
次要结局
- GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients(18 months)
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients(2 year)
- Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)(2 years)
- GFAP level in patients with relapse compared to stable patients(2 years)
- GFAP level in patients with isolated MRI activity compared to stable patients(6 months)
- Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.(2 years)
- Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients(2 years)
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients(2 years)
- Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement(2 years)
- Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion(Month 6)
- Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion(Month 6)
- GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.(2 years)
- Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients(2 years)
- Serum Neurofilament Light Chain level in patients with relapse compared to stable patients(2 years)
- Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients(2 years)
- Serum GFAP level in patients with isolated MRI activity compared to stable patients(2 years)
- Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort(2 years)
- Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)(2 years)
- Serum GFAP level in patients with MRI activity(2 years)
- Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement(2 years)
- Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement(2 years)
- Generic health status(active MRI (measured up to 2 years))
- Use of Disease Modifying Drugs(2 years)
- Create biobank(2 years)
- Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients(2 year)
- Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort(2 years)
- Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease(2 years)
- Serum GFAP level in patients with disease activity (relapse or MRI activity)(2 years)
- Serum GFAP level in patients with disease activity (relapse, or MRI activity)(6 months)
- Serum Neurofilament Light Chain level in patients with relapses(2 years)
- Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement(2 years)
- Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease(2 years)
- Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)(2 years)
- Serum Neurofilament Light Chain level in patients with disease activity (relapse, or MRI activity)(6 months)
- Serum GFAP level in patients with relapses(2 years)
- Serum Neurofilament Light Chain level in patients with MRI activity(2 years)
- Level of disability(Relapse (measured up to 2 years))
- Severity of multiple sclerosis(Active MRI (measured up to 2 years))
- Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients(Month 6)
- Serum GFAP in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients(Month 6)
研究者
研究点 (28)
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