Amyotrophic Lateral Sclerosis
Conditions
Brief summary
A multi-center registration study of natural history and clinical characteristics of ALS in mainland China
Detailed description
Amyotrophic lateral sclerosis (ALS) is a rapidly progressive neurodegenerative disease of unknown etiology that is currently incurable. This study is a national multi-center registration study. The study collects general information of ALS patients including medical history, disease characteristics, clinical treatment data, and patient information for different visits in different centers. The aim of the study is: a) describe the distribution of ALS in mainland China(explore the differences in the number of ALS at different times, different regions, and different populations) and further find the reasons that affect the distribution of ALS, b) study the development of ALS in mainland China and the corresponding changes in the characteristics of the disease, c) explore factors that influence the prognosis of ALS.
Interventions
None listed
Sponsors
Peking University Third Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to EI Escorial diagnostic criteria * Age: 18-70 years
Exclusion criteria
* Refuse to cooperate or reject the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Survival | through study completion, an average of 3 month | The length of time from the date of diagnosis to patient death or tracheotomy or ventilator-assisted breathing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | through study completion, an average of 3 month | The length of time from the date of diagnosis to patient death due to any cause or the last confirmed survival. |
| Rate of disease progression | through study completion, an average of 3 month | The slope of decline of the ALS Functional Rating Scale-Revised (ALSFRS-R) score from the diagnosis time to the follow-up time. ALSFRS-R values from 0 to 48 and it implies better outcome when it is higher. |
| Rate of Weight decline | through study completion, an average of 3 month | The slope of decline of weight |
| Rate of BMI decline | through study completion, an average of 3 month | The slope of decline of BMI |
| Rate of Forced Vital Capacity (FVC) | through study completion, an average of 3 month | The slope of decline of Forced Vital Capacity (FVC) to assess the respiratory function. |
Countries
China
Contacts
Primary ContactDongsheng Fan, MD, PhD
Outcome results
None listed