NCT04328675

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,752

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

March 20, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

April 28, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

March 17, 2020

Last Update Submit

April 26, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effective Survival

    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 Outcomes (5)

  • Overall Survival

    through study completion, an average of 3 month

  • Rate of disease progression

    through study completion, an average of 3 month

  • Rate of Weight decline

    through study completion, an average of 3 month

  • Rate of BMI decline

    through study completion, an average of 3 month

  • Rate of Forced Vital Capacity (FVC)

    through study completion, an average of 3 month

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to EI Escorial diagnostic criteria
  • Age: 18-70 years

You may not qualify if:

  • Refuse to cooperate or reject the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (1)

  • He J, Fu JY, Chen L, He J, Dang J, Zou Z, Ma S, Li N, Fan D. Multicentre, prospective registry study of amyotrophic lateral sclerosis in mainland China (CHALSR): study protocol. BMJ Open. 2020 Dec 4;10(12):e042603. doi: 10.1136/bmjopen-2020-042603.

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dongsheng Fan, MD, PhD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongsheng Fan, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 31, 2020

Study Start

March 20, 2020

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

April 28, 2020

Record last verified: 2020-03

Locations