NCT04860947进行中（未招募）不适用
Assessment of Serum Neurofilament-light Chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) Levels, Atrophy of the Macular Ganglion Cell Complex (GCC) by Optical Coherence Tomography (OCT) and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in Multiple Sclerosis Patients
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年6月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in serum Neurofilament Light Chain serum levels since baseline
研究概览
简要总结
The investigators hypothesize that serum neurofilament-light chain (NfL) levels at baseline and decrease of the macular ganglion cell complex (GCC) thickness at one year vs. baseline are as good as progression of whole brain atrophy at one year vs. baseline to predict later evolution of neurological disability in multiple sclerosis patients.
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
- •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 (≥)18 years old.
- •The patient has experienced a CIS, has currently a RRMS or progressive MS with:
- •Less than 10 years of disease duration;
- •With or without DMD;
- •EDSS score 0 - 7.0.
排除标准
- •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.
- •Patient has a bilateral optic neuritis or other significant ophthalmological antecedent.
- •Patient with MRI contra-indications.
- •patient has a contraindication to gadolinium injection
- •The patient has bilateral optic neuritis or other significant ophthalmological antecedent
- •Patient is having a relapse or has had a relapse in the last 3 months
- •The patient has a severe psychiatric illness
- •The patient has severe chronic alcoholism
结局指标
主要结局
Change in serum Neurofilament Light Chain serum levels since baseline
时间窗: Baseline; 1 year
pg/mL; measured by digital ELISA
Expanded Disability Status Scale
时间窗: 3 years
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Change in Ganglion Cell Complex thickness since baseline
时间窗: Baseline; 1 year
Measured by Optical Coherence Tomography
Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline
时间窗: Baseline; 1 year
pg/mL; measured by digital ELISA
Change in whole brain volume since baseline
时间窗: Baseline; 1 year
Assessed by MRI
次要结局
- Low contrast visual acuity(Any relapse (maximum 5 years))
- Grey matter atrophy(Any relapse (maximum 5 Years))
- Multiple Sclerosis Functional Composite(Any relapse (maximum 5 years))
- Time to walk 100 meters(Any relapse (maximum 5 years))
- 2 Minute walking distance(Any relapse (maximum 5 years))
- Cognitive Impairment(Any relapse (maximum 5 years))
- Thalamic atrophy(Any relapse (maximum 5 years))
- serum NfL levels(Any relapse (maximum 5 years))
- serum GFAP levels(Any relapse (maximum 5 years))
- White matter atrophy(Any relapse (maximum 5 years))
- Visual acuity(Any relapse (maximum 5 years))
- Relapse description(At relapse (maximum 5 years))
- Fatigue(Any relapse (maximum 5 years))
- Number of new lesions(At relapse (maximum 5 years))
- Whole brain volume(any relapse (max 5 years))
- Disease modifying drugs classification(until end of study (5 years))
- Impact of MS on daily life(Any relapse (maximum 5 years))
- Expanded Disability Status Scale(Any relapse (Maximum 5 years))
- Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness(Any relapse (maximum 5 Years))
- Gadolinium-enhanced lesions(Any relapse (Maximum 5 Years))
- T2 lesion volume,(Any relapse (maximum 5 years))
- Cognitive evaluation(Any relapse (maximum 5 years))
- Health-related quality of life(Any relapse (maximum 5 years))
研究者
研究点 (1)
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