NCT03367494

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

Terminated NA Last updated 22 June 2022

What this trial tests

NA trial testing Measurement of Sweat Chloride and Sweat Bromide in Cystic Fibrosis in 25 participants. Terminated before completion.

Timeline

1 March 2018

Primary endpoint
1 June 2020

1 December 2020

Quick facts

Lead sponsor	Milton S. Hershey Medical Center
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	25
Start date	1 March 2018
Primary completion	1 June 2020
Estimated completion	1 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Measurement of Sweat Chloride and Sweat Bromide

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Milton S. Hershey Medical Center

Who can join

18 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.