A Registered Cohort Study of Inflammatory Demyelination D... | NCT04386018

Studies
A Registered Cohort Study of Inflammatory Demyelination Disease

NCT04386018

Sponsor

Ning Wang, MD., PhD.

Status

Unknown status

Last Update Posted

Nov 13, 2020Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Demyelinating Autoimmune Diseases, CNS

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Apr 1, 2022Estimated

Completion Date

Apr 1, 2025Estimated

First Submitted Date

May 10, 2020

First Submission Date that Met QC Criteria

May 10, 2020

First Posted Date

May 13, 2020Actual

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

Nov 11, 2020

Last Update Posted Date

Nov 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ning Wang, MD., PhD., Director, First Affiliated Hospital of Fujian Medical UniversitySponsor-Investigator

Lead Sponsor

Ning Wang, MD., PhD.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study will provide further insights into the natural course of Inflammatory demyelination disease including clinical features，progression, related antibody spectrum and drug treatment effect

Detailed Description

Not provided

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

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The correlation between clinical phenotypes and Serum antibodies	Different clinical subtypes of Demyelinating Autoimmune Diseases have different course and prognosis.It may be related to different serum antibodies.	from date of enrollment until the date of death from any cause,assessed up to 20 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatient or inpatient
Meet the diagnostic criteria of Inflammatory Demyelination Disease.
Voluntary participation and informed consent signed by the applicant or his/her family.

Exclusion Criteria:

Severe complications
Poor prognosis (<1 year survival)
Severe mental disorder and inability to cooperate with the examination.

Accepts Healthy Volunteers

Yes

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

Patients with Inflammatory Demyelination Disease who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy by two neurolgists

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin Bi, BA	Contact	86-13673527355		2311306109@qq.com

Overall Officials

Not provided

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS

Ancestor Terms

ID	Term
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D056784	Leukoencephalopathies
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided