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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03367494
• Other study ID #: 00008612
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: June 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Diagnostic Test:
• Measurement of Sweat Chloride and Sweat Bromide
Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kim JP, Xie Z, Creer M, Liu Z, Yang J. Citrate-based fluorescent materials for low-cost chloride sensing in the diagnosis of Cystic Fibrosis. Chem Sci. 2017 Jan 1;8(1):550-558. doi: 10.1039/C6SC02962K. Epub 2016 Aug 30. — View Citation

Zhang C, Kim JP, Creer M, Yang J, Liu Z. A smartphone-based chloridometer for point-of-care diagnostics of cystic fibrosis. Biosens Bioelectron. 2017 Nov 15;97:164-168. doi: 10.1016/j.bios.2017.05.048. Epub 2017 May 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sweat chloride measurements in sweat samples via ion exchange chromatography	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).	anticipated 12 months
Primary	Sweat chloride measurements in sweat samples via fluorescence quenching	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).	anticipated 12 months
Primary	Sweat bromide measurements in sweat samples via fluorescence quenching	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).	anticipated 12 months