Tissue Repository for Studies of Myasthenia Gravis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Identification of New Antibodies in Myasthenia Gravis assessed by enzyme-linked immunosorbent assay (ELISA)
研究概览
简要总结
This is a study during which the investigators collect plasma and cells from patients with myasthenia gravis for the purpose of finding new antibodies.
详细描述
This is a bio-specimen collection study. The investigators will collect plasma and peripheral lymphocytes. Plasma will be collected either when the patient undergoes plasma exchange, a decision independent of this study, or through a scheduled blood draw.
Patient plasma will be screened for novel antibodies which may cause myasthenia gravis. Subjects that are found to be positive for candidate antigens for myasthenia gravis will have a clinical evaluation which will consist of several disease rating scales will be performed (QMG score, MG-composite, Myasthenia Gravis Foundation of America (MGFA) clinical classification, MG-Quality of Life (QOL)15, MGFA Therapy Status).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older.
- •Clinical Diagnosis of MG with supporting evidence either from antibody testing, repetitive nerve stimulations study (RNS) or Single Fiber Electromyography (EMG) (SFEMG).
排除标准
- •Significant medical condition that would make participation in diagnostic and research part of evaluation impossible or risky. Acute or unstable medical condition.
- •Inability to provide informed consent, either directly or via appointed power of attorney.
- •Unwillingness to consent for collection of biological samples or their cryopreservation.
- •Unable to provide evidence of previous antibody testing or neurophysiology confirming the diagnosis of Myasthenia Gravis.
- •Any bleeding disorder that would prevent or present any danger during blood extraction.
结局指标
主要结局
Identification of New Antibodies in Myasthenia Gravis assessed by enzyme-linked immunosorbent assay (ELISA)
时间窗: Up to 2 years
次要结局
未报告次要终点