NCT07143656进行中（未招募）不适用
Natural History and Biomarker Correlation Study in Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry
Biocells Medical1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年5月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Rate of decline in ALS Functional Rating Scale-Revised (ALSFRS-R) scores
研究概览
简要总结
This retrospective observational study will analyze de-identified clinical data from patients with amyotrophic lateral sclerosis (ALS) collected at multiple centers over 7 years. The primary objective is to describe disease progression using the ALS Functional Rating Scale-Revised (ALSFRS-R). Secondary objectives include evaluating survival, ventilatory decline, and correlations between available biomarkers (e.g., neurofilament light chain, cytokines) and disease trajectory. No new interventions or patient contact will occur.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of amyotrophic lateral sclerosis (ALS) or motor neuron disease confirmed.
- •Age ≥18 years.
- •Availability of at least one ALS Functional Rating Scale-Revised (ALSFRS-R) score.
- •Availability of longitudinal follow-up data.
排除标准
- •Patients with alternative diagnoses that mimic ALS (e.g., multifocal motor neuropathy, cervical myelopathy, myasthenia gravis).
- •Absence of medical records
结局指标
主要结局
Rate of decline in ALS Functional Rating Scale-Revised (ALSFRS-R) scores
时间窗: 2 yearss after the first administration
Unit: points per month
次要结局
未报告次要终点
研究者
研究点 (1)
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