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

Sponsor

Milton S. Hershey Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT03367494

Collaborator

(none)

Enrollment

Location

Arms

33.1

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Subjects with Cystic Fibrosis Diagnostic	Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors
Other: Healthy Volunteers Diagnostic	Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors

Arm

Intervention/Treatment

Other: Subjects with Cystic Fibrosis

Diagnostic

Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide

Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors

Other: Healthy Volunteers

Diagnostic

Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide

Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

Milton S. Hershey Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Robert Vender, Professor of Medicine, Milton S. Hershey Medical Center

ClinicalTrials.gov Identifier:

NCT03367494

Other Study ID Numbers:

00008612

First Posted:

Dec 8, 2017

Last Update Posted:

Jun 22, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cystic Fibrosis

Bromides

Study Results

No Results Posted as of Jun 22, 2022