Amyotrophic Lateral Sclerosis Registry

Not yet recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: Amyotrophic Lateral Sclerosis

• Registration Number: NCT05892822
• Lead Sponsor: yilong Wang

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-28
• Last Update Submitted: 2023-05-28
• Study First Posted: 2023-06-07
• Last Update Posted: 2023-06-07
• Study Start: 2023-06-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amyotrophic Lateral Sclerosis	Amyotrophic Lateral Sclerosis	This study is an observational study without grouping.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Exploring the imaging characteristics of ALS in the Chinese	day 1, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24	Record the change of the patient's head MRI from baseline through follow-up every 3 months.
Establishing an iPSCs library for ALS in the Chinese	day 1	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.
Analysis of the correlation between electrophysiology characteristics and imaging characteristics of ALS in Chinese	day 1, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24	Record the progression of the disease from an electrophysiological and imaging perspective by conducting electromyography and head MRI every 3 months.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China