NCT04008329

Brief Summary

Amyotrophic lateral sclerosis (ALS) is a kind of motor neuron degeneration disorder without effective therapy. This registered cohort study will provide further insights into the clinical course of ALS, and investigate disease-relative risk factors and the genetic background of Chinese ALS patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
401mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress18%
Jul 2019Jul 2059

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
30 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2059

Last Updated

March 22, 2021

Status Verified

February 1, 2021

Enrollment Period

10 years

First QC Date

July 1, 2019

Last Update Submit

March 18, 2021

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosisnatural historygeneticsprognostic factors

Outcome Measures

Primary Outcomes (2)

  • Age at death

    the time when patient die

    10 years

  • Age of endotracheal intubation or tracheotomy

    the time for the patient accepted endotracheal intubation or tracheotomy

    10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ALS patients who are diagnosed in the First Affiliated Hospital of Fujian Medical University

You may qualify if:

  • Amyotrophic Lateral Sclerosis patients fulfilling the El Escorial criteria (including definite, probable and possible)
  • Progressive muscular atrophy
  • Primary lateral sclerosis
  • Progressive bulbar palsy

You may not qualify if:

  • History of serious head trauma or neuropsychiatric disease
  • Decline to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

Related Publications (1)

  • Liu K, Guo Q, Ding Y, Luo L, Huang J, Zhang Q. Alterations in nasal microbiota of patients with amyotrophic lateral sclerosis. Chin Med J (Engl). 2024 Jan 20;137(2):162-171. doi: 10.1097/CM9.0000000000002701. Epub 2023 Jul 21.

    PMID: 37482646DERIVED

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

  • Ning Wang, MD,PhD

    First Affiliated Hospital of Fujian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi-Jie Zhang, PhD

CONTACT

086-591-87982772qijiezhang86@fjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

July 5, 2019

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2059

Last Updated

March 22, 2021

Record last verified: 2021-02

Locations

CN(1)