Cystic Fibrosis
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTMeasurement of Sweat Chloride and Sweat Bromide
Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sweat chloride measurements in sweat samples via ion exchange chromatography | 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 chloride measurements in sweat samples via fluorescence quenching | 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 bromide measurements in sweat samples via fluorescence quenching | 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). |
Countries
United States
Outcome results
None listed