An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit

NCT04388072 | Completed DMC

• 1 other identifier: LS2019-004-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuromyelitis Optica Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead
• MyBiotech Co. Ltd, China: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (2)

Department of Neurology,First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 14, 2020
• Study Start: May 15, 2020
• Primary Completion: December 1, 2020
• Study Completion: February 20, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-01

Locations

CN (2)