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临床试验/NCT02587728
NCT02587728已完成不适用

Collection of Peripheral Blood Samples From Patients With Carpal Tunnel Syndrome for Laboratory Screening of Amyloidosis

University of Miami1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年2月24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
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Hoffman, MD

Associate Professor of Clinical

University of Miami

研究点 (1)

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