A Registered Cohort Study on Amyotrophic Lateral Sclerosis | NCT04008329

Studies
A Registered Cohort Study on Amyotrophic Lateral Sclerosis

NCT04008329

Sponsor

First Affiliated Hospital of Fujian Medical University

Status

Recruiting

Last Update Posted

Mar 22, 2021Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2019Actual

Primary Completion Date

Jul 2029Estimated

Completion Date

Jul 2059Estimated

First Submitted Date

Jul 1, 2019

First Submission Date that Met QC Criteria

Jul 2, 2019

First Posted Date

Jul 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2021

Last Update Posted Date

Mar 22, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ning Wang, MD., PhD., Professor, First Affiliated Hospital of Fujian Medical UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Fujian Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease (MND), which is characterized with highly clinical heterogeneity and no effective treatment is available now. The purpose of this registered cohort is to observe the natural history of ALS patients in China, and then identify some factors correlated with disease progression. Besides, ALS-related gene mutations will be screened and explore novel disease causing gene as well.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

History of serious head trauma or neuropsychiatric disease
Decline to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qi-Jie Zhang, PhD	Contact	086-591-87982772		qijiezhang86@fjmu.edu.cn

Overall Officials

Name	Affiliation	Role
Ning Wang, MD,PhD	First Affiliated Hospital of Fujian Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, First Affiliated Hospital of Fujian Medical University	Recruiting	Fuzhou	Fujian	350005	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37482646	Derived	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.

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease