Cystic FibrosisNCT02404714
A Multi-Center Study of the CF Quantum® Sweat Test System
An observational study of Cystic Fibrosis, run by Polychrome Medical, Inc. at 6 sites in United States.
Trial summary
This is an observational comparative study to compare the standard-of-care methods for sweat testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat testing called the CF Quantum Sweat Test System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Iontophoresis sweat test
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 6 sitesUnited States
- Study dates
- 8 Feb 2017to 1 Jul 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes those individuals with a previous diagnosis of CF or cystic fibrosis related metabolic syndrome (CRMS) and those individuals who have been referred to the sweat test lab for clinical reasons by a physician. The groups will be selected from the investigator's normal clinical practice.
Who may be able to join
- Patients referred to the sweat test lab on a clinical basis.
- Infants who require a sweat test as follow-up to an abnormal CF screening test.
- Patients who have already been diagnosed with CF or CRMS.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative.
Who cannot join
- Patient is receiving oxygen by open delivery.
- Infants less than 48 hours of age.
- Diffuse inflammation or rash on the collection site.
- Patients who have had a reaction to a prior iontophoretic sweat test procedure.
- Arm is too small for both the new and conventional sweat test.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan-Ann Arbor, Cystic Fibrosis Center
Ann Arbor, Michigan, 48109
Children's Hospital of Alabama at UAB
Birmingham, Alabama, 35233
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Dayton Children's Hospital
Dayton, Ohio, 45404
University of Wisconsin-Madison CF Center
Madison, Wisconsin, 53792
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55454
About this study
Official title: A Multi-Center Study of A New Method of Sweat Testing: The CF Quantum® Sweat Test
This is an observational comparative study to compare the standard-of-care methods for sweat testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat testing called the CF Quantum Sweat Test System. The results of the new device in this study are for comparison ONLY and will NOT be used to diagnose, treat or mitigate the subject's condition.
Read the detailed description
The primary objective is to evaluate the diagnostic accuracy of a new sweat test method in both normal individuals and individuals with CF or cystic fibrosis related metabolic syndrome (CRMS).
Subject participation is for one day and duration of study for each subject is one day. No follow-up will be required.
Number of subjects; 300 split evenly between subjects with previously diagnosed CF or CRMS (cystic fibrosis related metabolic syndrome) and subjects referred to the sweat test lab for clinical reasons.
Number of sites = 6, U of WI-Madison, U of WI-Milwaukee, U of MI-Ann Arbor, Dayton Children's Hospital (OH), U of MN, and Children's of Alabama.
Primary endpoints:
- Clinical and analytical sensitivity of the new test method
- Clinical and analytical sensitivity of the standard-of-care methods
Statistics Sensitivity and specificity will be calculated and reported along with the corresponding 95% confidence intervals. Bias assessment will be conducted according to the Clinical and Laboratory Standards Institute (CLSI) guidelines for method comparison and bias estimation. Pearson's correlation analysis will be conducted to test for adequate range of the replicate values for the new test method.
- Conditions
- Cystic Fibrosis
- Being tested
- Iontophoresis sweat test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iontophoresis sweat testDevice
The intervention is iontophoretic sweat testing which includes the stimulation, collection and analysis of sweat. The standard of care sweat testing used at each institution will be compared to a new iontophoresis sweat test called the CF Quantum.
| Study group | Role | What they receive |
|---|---|---|
| CF/CRMS | Subject's with a previous cystic fibrosis or cystic fibrosis related metabolic syndrome (CRMS) diagnosis will receive the institution's standard iontophoresis sweat testing (Gibson-Cooke or Wescor Macroduct) to provide a diagnosis.
The patient will also receive a sweat test provided by the new CF Quantum Sweat Test System which includes the same process and principal of operation of iontophoretic stimulation, collection and analysis of sweat compared to the standard. The results of the new sweat test and the standard sweat test will be compared. The new sweat test will not be used to diagnose, treat or mitigate the patient's condition. Results are used only to compare to the standard of care. Receives: Device: Iontophoresis sweat test | |
| NON CF/CRMS | Subject's without a previous cystic fibrosis or cystic fibrosis related metabolic syndrome (CRMS) diagnosis but referred to the sweat test lab on a clinical observation basis by a physician will receive standard iontophoresis sweat testing (Gibson-Cooke or Wescor Macroduct) to provide a diagnosis.
The patient will also receive a sweat test provided by the new CF Quantum Sweat Test System which includes the same process and principal of operation of iontophoretic stimulation, collection and analysis of sweat compared to the standard. The results of the new sweat test and the standard sweat test will be compared. The new sweat test will not be used to diagnose, treat or mitigate the patient's condition. Results are used only to compare to the standard of care. Receives: Device: Iontophoresis sweat test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity and specificity (true positive rate and the false negative rate to measure chloride in the sweat sample) of the new sweat test device compared to the standard-of-care sweat test device
Measured: Day 1
Secondary outcomes (1)
Compare the sweat test's "quantity not sufficient" (QNS) rate of the new device to the standard-of-care device.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start8 Feb 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: Study funding has been withdrawn. No adverse safety issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polychrome Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Rock, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404714
- Sponsor's protocol ID
- CFQuantum003
- Status last verified
- Aug 2018
- First submitted
- 16 Mar 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study of A New Method of Sweat Testing: The CF Quantum® Sweat Test
- ClinicalTrials.gov ID
- NCT02404714
- Acronym / sponsor ID
- CFQuantum003
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study funding has been withdrawn. No adverse safety issues.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Polychrome Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 31 Mar 2015 (estimated)
- 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.
This is an observational comparative study to compare the standard-of-care methods for sweat testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat testing called the CF Quantum Sweat Test System. The results of the new device in this study are for comparison ONLY and will NOT be used to diagnose, treat or mitigate the subject's condition.
Detailed description
The primary objective is to evaluate the diagnostic accuracy of a new sweat test method in both normal individuals and individuals with CF or cystic fibrosis related metabolic syndrome (CRMS).
Subject participation is for one day and duration of study for each subject is one day. No follow-up will be required.
Number of subjects; 300 split evenly between subjects with previously diagnosed CF or CRMS (cystic fibrosis related metabolic syndrome) and subjects referred to the sweat test lab for clinical reasons.
Number of sites = 6, U of WI-Madison, U of WI-Milwaukee, U of MI-Ann Arbor, Dayton Children's Hospital (OH), U of MN, and Children's of Alabama.
Primary endpoints:
- Clinical and analytical sensitivity of the new test method
- Clinical and analytical sensitivity of the standard-of-care methods
Statistics Sensitivity and specificity will be calculated and reported along with the corresponding 95% confidence intervals. Bias assessment will be conducted according to the Clinical and Laboratory Standards Institute (CLSI) guidelines for method comparison and bias estimation. Pearson's correlation analysis will be conducted to test for adequate range of the replicate values for the new test method.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF/CRMS | – | Device: Iontophoresis sweat testSubject's with a previous cystic fibrosis or cystic fibrosis related metabolic syndrome (CRMS) diagnosis will receive the institution's standard iontophoresis sweat testing (Gibson-Cooke or Wescor Macroduct) to provide a diagnosis. The patient will also receive a sweat test provided by the new CF Quantum Sweat Test System which includes the same process and principal of operation of iontophoretic stimulation, collection and analysis of sweat compared to the standard. The results of the new sweat test and the standard sweat test will be compared. The new sweat test will not be used to diagnose, treat or mitigate the patient's condition. Results are used only to compare to the standard of care. |
| NON CF/CRMS | – | Device: Iontophoresis sweat testSubject's without a previous cystic fibrosis or cystic fibrosis related metabolic syndrome (CRMS) diagnosis but referred to the sweat test lab on a clinical observation basis by a physician will receive standard iontophoresis sweat testing (Gibson-Cooke or Wescor Macroduct) to provide a diagnosis. The patient will also receive a sweat test provided by the new CF Quantum Sweat Test System which includes the same process and principal of operation of iontophoretic stimulation, collection and analysis of sweat compared to the standard. The results of the new sweat test and the standard sweat test will be compared. The new sweat test will not be used to diagnose, treat or mitigate the patient's condition. Results are used only to compare to the standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes those individuals with a previous diagnosis of CF or cystic fibrosis related metabolic syndrome (CRMS) and those individuals who have been referred to the sweat test lab for clinical reasons by a physician. The groups will be selected from the investigator's normal clinical practice.
Key inclusion criteria (4 listed)
- Patients referred to the sweat test lab on a clinical basis.
- Infants who require a sweat test as follow-up to an abnormal CF screening test.
- Patients who have already been diagnosed with CF or CRMS.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative.
Key exclusion criteria (5 listed)
- Patient is receiving oxygen by open delivery.
- Infants less than 48 hours of age.
- Diffuse inflammation or rash on the collection site.
- Patients who have had a reaction to a prior iontophoretic sweat test procedure.
- Arm is too small for both the new and conventional sweat test.
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 |
|---|---|---|
| Iontophoresis sweat testThe intervention is iontophoretic sweat testing which includes the stimulation, collection and analysis of sweat. The standard of care sweat testing used at each institution will be compared to a new iontophoresis sweat test called the CF Quantum. | Device | CF/CRMS, NON CF/CRMS |
Primary outcome
Diagnostic sensitivity and specificity (true positive rate and the false negative rate to measure chloride in the sweat sample) of the new sweat test device compared to the standard-of-care sweat test device
Time frame: Day 1
1 secondary outcome
Compare the sweat test's "quantity not sufficient" (QNS) rate of the new device to the standard-of-care device.
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Study funding has been withdrawn. No adverse safety issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Michael Rock, MD principal investigator
University of Wisconsin, Madison
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Polychrome Medical, Inc. at 6 sites 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 4 inclusion and 5 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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: Study funding has been withdrawn. No adverse safety issues.). 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?
Diagnostic sensitivity and specificity (true positive rate and the false negative rate to measure chloride in the sweat sample) of the new sweat test device compared to the standard-of-care sweat test device (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2018.