Collection of Peripheral Blood Samples From Patients With Carpal Tunnel Syndrome for Laboratory Screening of Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants Identified with Amyloidosis
研究概览
简要总结
Carpal tunnel is an early manifestation of amyloidosis in a significant minority of patients. This specimen collection protocol will allow the investigators to screen patients with carpal tunnel syndrome for amyloidosis.
详细描述
The investigators propose to assess a high risk population of patients, those with carpal tunnel syndrome, and systematically assess them for Amyloid Light-chain (AL) amyloidosis and Transthyretin-Related Amyloidosis (ATTR) with simple laboratory blood tests. The combination of serum immunofixation electrophoresis together with serum free light chain (FLC) assay approaches 100% sensitivity for identifying the monoclonal protein underlying the illness in patients with AL amyloidosis. In addition to this, testing for transthyretin gene mutations will allow the investigators to identify patients with ATTR. The investigators believe this simple screening panel (serum immunofixation and serum FLC assay and transthyretin mutation analysis) may allow the investigators to identify patients early in the course of their disease, at which point the investigators can intervene with effective treatment and spare patients a significant amount of morbidity and mortality.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosed carpal tunnel syndrome based on Electromyography (EMG) results.
- •Patients with electrographic confirmation of median neuropathy at the wrist
- •Age ≥18 years
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Patients receiving hemodialysis
- •Known amyloidosis
结局指标
主要结局
Number of Participants Identified with Amyloidosis
时间窗: Up to 5 years
Number of carpal tunnel syndrome patients identified with amyloidosis, which will be stratified into mild, moderate or severe
次要结局
未报告次要终点
研究者
James Hoffman, MD
Associate Professor of Clinical
University of Miami
