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临床试验/NCT03367494
NCT03367494终止不适用

A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
2
主要终点
Sweat chloride measurements in sweat samples via fluorescence quenching

研究概览

简要总结

Cystic Fibrosis (CF) is a hereditary multi-system disease affecting approximately 30,000n children and adults in the USA. The diagnosis of CF requires biochemical confirmation (either abnormal sweat chloride measurement and/or identification of two CF disease causing mutations) plus clinical symptomatology. Measurements of sweat chloride remain cumbersome and although most common methodology to confirm CF diagnosis with limitations especially in young children less than 6 months of age and in areas that lack ability for the complex testing. The study objectives of this current research proposal include: A) To expand upon previously obtained pilot study data "Evaluation of a fluorescent-based chloride sensor as an optical sweat test to diagnose cystic fibrosis" B) To add the exploratory measurement of sweat Bromide as a first in human assessment observation, C) To Evaluate the development of smartphone based point-of-care technology for chloride and bromide sensor measurements, D) To further expand the class of citrate-based sensors with improved fluorescence and sensing properties for the design of new fluorescence-based analytical and diagnostic solutions based on the automated multi-halide detection system, and E) To develop point-of-care systems that can successfully integrate into clinical settings to improve current practices and facilitate early detection of disease.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • Adults 18 years of age or older capable of providing written informed consent AND
  • Patients with an established diagnosis of Cystic Fibrosis (CF) OR Healthy volunteers

排除标准

  • Participants under medications or with disorders known to cause a positive error in the sweat test will be excluded in the study. Common causes of positive error in sweat test are mineralocorticoid hormone therapy, adrenal insufficiency, glycogen storage diseases, hypothyroidism, hypoparathyroidism, nephrogenic diabetes insipidus, G6PD deficiency or ectodermal dysplasia OR
  • Any other skin or soft tissue disorders that could affect obtaining the necessary volumes of sweat.

结局指标

主要结局

Sweat chloride measurements in sweat samples via fluorescence quenching

时间窗: anticipated 12 months

Sweat specimen samples obtained via pilocarpine iontophoresis will be measured for sweat chloride. Measurements for the chloride will be determined by fluorescence citrate-based sensors, measured in millimolar (mM).

Sweat chloride measurements in sweat samples via ion exchange chromatography

时间窗: anticipated 12 months

Sweat specimen samples obtained via pilocarpine iontophoresis will be measured for sweat chloride. Measurements for chloride will be determined by ion exchange chromatography measured in millimolar (mM).

Sweat bromide measurements in sweat samples via fluorescence quenching

时间窗: anticipated 12 months

Sweat specimen samples obtained via pilocarpine iontophoresis will be measured for sweat bromide. Measurements for bromide will be determined by fluorescence citrate-based sensors, measured in millimolar (mM).

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

Robert Vender

Professor of Medicine

Milton S. Hershey Medical Center

研究点 (2)

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