NCT06318598招募中不适用
Dissezione Fenotipica Guidata da Biomarcatori Della Sclerosi Laterale Amiotrofica/Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- biomarker assessment
研究概览
简要总结
The goal of this observational study is to understand the clinical variability in a population of ALS patients using multidimensional biomarkers. The main questions it aims to answer are:
- Which set of biomarkers explain genotypic-phenotypic correlations in ALS?
- Which set of biomarkers can be used to subdivide the ALS population in homogeneous subgroups?
Participants will undergo:
- neurological evaluation
- neurophysiological evaluation
- neuropsychological evaluation
- whole exome sequencing
- biomarker measurement in CSF and plasma
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •diagnosis of ALS or other motor neuron disease
- •residence near the study centers
排除标准
- •refusal to participate to the study
- •unable/unwilling to perform follow-up visits
结局指标
主要结局
biomarker assessment
时间窗: baseline (at diagnosis), at 6 months, at 1 year
no. of patients with abnormal NfL, GFAP, tau, UCHL1, MCP1 and TDP-43 levels
genetic screening
时间窗: baseline (at diagnosis)
no. of patients with ALS-associated mutations
次要结局
- neuropsychological assessment(baseline (at diagnosis), at 1 year)
- clinical assessment(baseline (at diagnosis), at 6 months, at 1 year)
研究者
研究点 (3)
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