Registration Study of Amyotrophic Lateral Sclerosis (ALS) in Mainland China (ChALSR)

April 26, 2020 updated by: Peking University Third Hospital

Registration Study of Natural History and Clinical Characteristics of Amyotrophic Lateral Sclerosis (ALS) in Mainland China

A multi-center registration study of natural history and clinical characteristics of ALS in mainland China

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

4752

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dongsheng Fan, MD, PhD
  • Phone Number: +86-15611908107
  • Email: dsfan@sina.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who meet the criteria will be enrolled from multi-centers in mainland China.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective Survival
Time Frame: 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.
through study completion, an average of 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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.
through study completion, an average of 3 month
Rate of disease progression
Time Frame: 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.
through study completion, an average of 3 month
Rate of Weight decline
Time Frame: through study completion, an average of 3 month
The slope of decline of weight
through study completion, an average of 3 month
Rate of BMI decline
Time Frame: through study completion, an average of 3 month
The slope of decline of BMI
through study completion, an average of 3 month
Rate of Forced Vital Capacity (FVC)
Time Frame: through study completion, an average of 3 month
The slope of decline of Forced Vital Capacity (FVC) to assess the respiratory function.
through study completion, an average of 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Dongsheng Fan, MD, PhD, Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2020

Primary Completion (Anticipated)

March 20, 2023

Study Completion (Anticipated)

March 20, 2023

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 29, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 26, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDongsheng-81873784

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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