Study Stopped
Investigator Decision
A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJune 22, 2022
June 1, 2022
2.3 years
November 22, 2017
June 20, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
Subjects with Cystic Fibrosis
OTHERDiagnostic
Healthy Volunteers
OTHERDiagnostic
Interventions
Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Related Publications (2)
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.
PMID: 28595077BACKGROUNDKim 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.
PMID: 28348728BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
November 22, 2017
First Posted
December 8, 2017
Study Start
March 1, 2018
Primary Completion
June 1, 2020
Study Completion
December 1, 2020
Last Updated
June 22, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
No personally identifiable information will be communicated to investigators at PSU-University Park. Sweat samples will be identified solely by code which code will be linked to personally identifiable information known only to Dr. Vender and which code will be kept in a locked office at Hershey Medical Center (HMC) Biomedical Research Building C5860. This code will contain participant (both CF patients and healthy volunteers): name, HMC medical record #, age, gender, date of sample, date of birth and sweat chloride/bromide results. In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared. Personally identifiable health information access (such as diagnosis, name, HMC medical record#, age, gender, date of birth) is specifically for Cystic Fibrosis patients. Medical records and health information will NOT be accessed for healthy control volunteers, however name, age, gender, date of birth will be recorded.