An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit

Neuromyelitis Optica Spectrum Disorders Clinical Trial

Official title:

An Diagnostic Cohort on Applicability and Accuracy of AQP4-Immunoglobulin G Detection Kit in the Diagnosis of Neuromyelitis Optica Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388072
• Other study ID #: LS2019-004-02
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: February 20, 2021

Study information

• Verified date: January 2022
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 20, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The patients who were diagnosed with NMOSD , and the cell-based assay was used to determine the AQP4-IgG-seropositive patients;

2. AQP4-IgG is negative in health people with age and sex matching and determined by cell-based assay;

3. Female or male, age 14-80;

4. Patients or authorized family members volunteered to participate in this study and signed informed consent.

Exclusion Criteria:

1. Patients with coagulation disorders;

2. Infection-related encephalitis;

3. Immune-related encephalitis;

4. A patient with severe mental illness who cannot cooperate clinically;

5. A patient with severe jaundice.

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorders

Locations

Country	Name	City	State
China	Department of Neurology,First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Third Affiliated Hospital of Sun Yat-sen University	Guangzhou

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University	MyBiotech Co. Ltd, China, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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