NCT04388072已完成不适用
An Diagnostic Cohort on Applicability and Accuracy of AQP4-Immunoglobulin G Detection Kit in the Diagnosis of Neuromyelitis Optica Spectrum Disorders
First Affiliated Hospital of Fujian Medical University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- results of AQP4 -immunoglobulin G detection kit
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
results of AQP4 -immunoglobulin G detection kit
时间窗: through study completion, an average of 6 months
The Serum test results of participants using AQP4 -immunoglobulin G detection kit
次要结局
未报告次要终点
研究者
Ning Wang, MD., PhD.
Director
First Affiliated Hospital of Fujian Medical University
研究点 (2)
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