Staging System in Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers.
研究概览
简要总结
Recently two staging systems have been proposed for amyotrophic lateral sclerosis (ALS), based on clinical milestones The King's college clinical staging system (1) and ALS Milano-Torino Staging (ALS-MITOS) (2). Further research to validate and develop an accurate staging system in different populations will improve our understanding of its pathogenesis, disease activity and progression.
General objective : To validate the two previously proposed staging system and to test the interest of considering Neurofilament biomarkers in these systems.
Specific objectives: 1) To validate the two classification systems in an independent cohort of patients with ALS followed-up in the ALS expert center of Limoges (France) 2) To assess the interest of Nf biomarkers to predict neurological decline
详细描述
Amyotrophic lateral sclerosis (ALS) is a rare, fatal neurodegenerative disease of the human motor system. Recently two new staging systems have been proposed for ALS, based on clinical milestones related also to the spreading pattern of the disease (1,2). Furthermore, biomarker development is still an essential component of future therapeutic development in ALS. Thus, it is also important to acknowledge the value of biomarker research in supporting or revealing fundamental pathophysiological mechanisms in ALS.
The proposed staging systems: have been recently tested in two independent cohorts (3,4) with results that were not fully consistent (ii) did not considered the potential value of biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALS cases recruited for retrospectively (between) 2007 to 2016 for the retrospective cohort
- •ALS cases recruited for prospectively by the ALS expert center of Limoges for one year.
排除标准
- •Previous neurosurgical operations
- •A recent history of neurotrauma
- •Peripheral neuropathies
- •ALS/frontotemporal dementia (ALS/FTD)
结局指标
主要结局
To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers.
时间窗: 2 years
To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers
次要结局
未报告次要终点