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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subjects with Cystic Fibrosis

Diagnostic

Group Type OTHER

Measurement of Sweat Chloride and Sweat Bromide

Intervention Type DIAGNOSTIC_TEST

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

Healthy Volunteers

Diagnostic

Group Type OTHER

Measurement of Sweat Chloride and Sweat Bromide

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Measurement of Sweat Chloride and Sweat Bromide

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes