Amyotrophic Lateral Sclerosis Registry

Study Overview
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Brief Summary
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This study takes amyotrophic lateral sclerosis (ALS) patients as the main research object. Through collecting genetics, imaging and clinical symptoms for Exploratory research, we will construct the gene spectrum of ALS in China, explore unknown pathogenic genes, explore the characteristic image characteristics of ALS, and establish the iPSCs library of ALS, providing resources and basis for the research of pathogenesis and treatment targets of ALS.

Detailed Description
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This study is a multicenter, prospective registration study that will follow up patients with clinically confirmed and suspected amyotrophic lateral sclerosis for a period of 2 years. A total of 1000 patients will be included to dynamically observe the changes in clinical symptoms and signs, imaging, electrophysiology, biomarkers, biological samples and so on, which will construct a genetic profile of ALS in China, explore the etiology and pathogenesis, and establish an iPSCs library, provide a basis for finding treatment targets.

Official Title
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Amyotrophic Lateral Sclerosis Registry

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Other: Amyotrophic Lateral Sclerosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old ≤ age ≤ 80 years old; Patients are diagnosed definite or probable ALS according to the Awaji diagnostic criteria; Sign an informed consent form. Exclusion Criteria: Unable to cooperate with research or complete follow-up due to geographical or other reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amyotrophic Lateral Sclerosis<br>This study is an observational study without grouping. | Other: Amyotrophic Lateral Sclerosis<br>* All ALS patients included in this group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene Mutation Characteristics of ALS in Chinese | Constructing a Chinese ALS genetic information database by collecting genetic information from patients. | day 1 | 
| The disease development of ALS in the Chinese | Record the progress of patients' clinical symptoms from baseline through 2-year follow-up. | month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploring the imaging characteristics of ALS in the Chinese | Record the change of the patient's head MRI from baseline through follow-up every 3 months. | day 1, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 | 
| Establishing an iPSCs library for ALS in the Chinese | 100 fALS and clinically typical sALS were selected. Monocytes were isolated from peripheral blood collected at baseline, and Reprogramming into iPSCs to establish iPSCs library. | day 1 | 
| Analysis of the correlation between electrophysiology characteristics and imaging characteristics of ALS in Chinese | Record the progression of the disease from an electrophysiological and imaging perspective by conducting electromyography and head MRI every 3 months. | day 1, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyotrophic lateral sclerosis