Cystic FibrosisNCT03367494
A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor
A study testing Measurement of Sweat Chloride and Sweat Bromide in people with Cystic Fibrosis, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Measurement of Sweat Chloride and Sweat Bromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Measurement of Sweat Chloride and Sweat Bromide
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Sweat Chloride and Sweat BromideDiagnostic test
Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Cystic Fibrosis | Other | Diagnostic Receives: Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide |
| Healthy Volunteers | Other | Diagnostic Receives: Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: anticipated 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Mar 2018
- Primary completion1 Jun 2020
- Study completion1 Dec 2020
Why it stopped: Investigator Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Vender, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367494
- Sponsor's protocol ID
- 00008612
- Status last verified
- Jun 2022
- First submitted
- 22 Nov 2017
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 28595077Kim 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.
PubMed 28348728
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor
- ClinicalTrials.gov ID
- NCT03367494
- Acronym / sponsor ID
- 00008612
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator Decision
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Cystic Fibrosis | Other | Diagnostic Test: Measurement of Sweat Chloride and Sweat BromideDiagnostic |
| Healthy Volunteers | Other | Diagnostic Test: Measurement of Sweat Chloride and Sweat BromideDiagnostic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of Sweat Chloride and Sweat BromideSweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors | Diagnostic test | Healthy Volunteers, Subjects with Cystic Fibrosis |
Primary outcome
Sweat chloride measurements in sweat samples via ion exchange chromatography
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
The study was stopped early (reason given: Investigator Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Background: PubMed 28595077Zhang 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.
- Background: PubMed 28348728Kim 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of Sweat Chloride and Sweat Bromide in people with Cystic Fibrosis, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sweat chloride measurements in sweat samples via ion exchange chromatography (time frame: anticipated 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03367494, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.