NCT03367494

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Measurement of Sweat Chloride and Sweat Bromide	Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-06-01
• Completion: 2020-12-01
• First posted: 2017-12-08
• Last updated: 2022-06-22

Locations

1 site across 1 country: United States