A Prospective, Multicenter Registry Study of Amyotrophic Lateral Sclerosis in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
This is a prospective, observational, multicenter registry designed to collect comprehensive clinical, genetic, and outcome data from patients diagnosed with amyotrophic lateral sclerosis (ALS) across Thailand. The registry will establish a national dataset to describe epidemiology, clinical presentation, progression, and treatment outcomes, and will serve as a platform for future clinical and translational research.
详细描述
Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder that affects upper and lower motor neurons, leading to progressive muscle weakness, disability, and respiratory failure. Despite increasing research worldwide, Thailand lacks large-scale systematic data on ALS epidemiology, clinical characteristics, genetic profiles, and outcomes.
This registry will prospectively enroll ALS patients from major academic hospitals and specialized neuromuscular centers nationwide. Patients will be followed longitudinally using standardized assessments, including ALSFRS-R, staging systems (King, MiTos, 9-point), motor and respiratory function, quality-of-life measures, and cognitive/behavioral evaluations.
Data will be collected through a REDCap electronic database, ensuring confidentiality and compliance with Thai PDPA and international data protection standards. No experimental interventions will be performed; patients will receive standard of care treatments as determined by their treating physicians.
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
- •Diagnosis of ALS according to El Escorial or Gold Coast criteria
- •Age ≥ 18 years
- •Ability and willingness to provide informed consent
排除标准
- •Patients unwilling to provide informed consent
- •Patients with alternative diagnoses mimicking ALS
结局指标
主要结局
Survival
时间窗: 10 years
Time Frame: From enrollment until death from any cause (assessed continuously, with updates at each follow-up). Outcome: Overall survival in ALS patients across Thailand, with survival curves stratified by demographic, clinical, and genetic factors.
次要结局
- ALS Functional Decline(10 years)
- Disease Staging Progression(10 years)
- Respiratory Outcomes(10 years)
- Changes in health-related quality of life over time.(10 years)
- Cognitive and Behavioral Profile(10 years)
- Healthcare Utilization and Treatment Patterns(10 years)
- Genetic and Environmental Risk Associations(10 years)
研究者
Jakkrit Amornvit, MD.
Priciple Investigator
Chulalongkorn University