An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit | NCT04388072

Studies
An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit

NCT04388072

Sponsor

First Affiliated Hospital of Fujian Medical University

Status

Completed

Last Update Posted

Feb 3, 2022Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Neuromyelitis Optica Spectrum Disorders

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Feb 20, 2021Actual

First Submitted Date

May 10, 2020

First Submission Date that Met QC Criteria

May 13, 2020

First Posted Date

May 14, 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

Jan 19, 2022

Last Update Posted Date

Feb 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

First Affiliated Hospital of Fujian Medical UniversityOTHER

Collaborators

Name	Class
MyBiotech Co. Ltd, China	UNKNOWN
Third Affiliated Hospital, Sun Yat-Sen University	OTHER

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

The diagnostic cohort study could will be use to verify the clinical performance of the AQP4 -immunoglobulin G detection kit and whether it has a good correlation with the clinical diagnosis results. The applicability and accuracy of the kit in clinical diagnosis will be verified according to the measured data.

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

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
results of AQP4 -immunoglobulin G detection kit	The Serum test results of participants using AQP4 -immunoglobulin G detection kit	through study completion, an average of 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients who were diagnosed with NMOSD , and the cell-based assay was used to determine the AQP4-IgG-seropositive patients;
AQP4-IgG is negative in health people with age and sex matching and determined by cell-based assay;
Female or male, age 14-80;
Patients or authorized family members volunteered to participate in this study and signed informed consent.

Exclusion Criteria:

Patients with coagulation disorders;
Infection-related encephalitis;
Immune-related encephalitis;
A patient with severe mental illness who cannot cooperate clinically;
A patient with severe jaundice.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D009471	Neuromyelitis Optica

Ancestor Terms

ID	Term
D009188	Myelitis, Transverse
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided