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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03367494
Date of registration: 22/11/2017
Prospective Registration: Yes
Primary sponsor: Milton S. Hershey Medical Center
Public title: A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor
Scientific title: A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor
Date of first enrolment: March 1, 2018
Target sample size: 50
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03367494
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Intervention(s)
Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide
Primary Outcome(s)
Sweat bromide measurements in sweat samples via fluorescence quenching [Time Frame: anticipated 12 months]
Sweat chloride measurements in sweat samples via fluorescence quenching [Time Frame: anticipated 12 months]
Sweat chloride measurements in sweat samples via ion exchange chromatography [Time Frame: anticipated 12 months]
Secondary Outcome(s)
Secondary ID(s)
00008612
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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