Study Stopped
Study funding has been withdrawn. No adverse safety issues.
A Multi-Center Study of the CF Quantum® Sweat Test System
A Multi-Center Study of A New Method of Sweat Testing: The CF Quantum® Sweat Test
1 other identifier
observational
55
1 country
6
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2017
6 active sites
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
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedStudy Start
First participant enrolled
February 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 31, 2018
August 1, 2018
1.4 years
March 16, 2015
August 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
Day 1
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Children's Hospital of Alabama at UAB
Birmingham, Alabama, 35233, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
University of Michigan-Ann Arbor, Cystic Fibrosis Center
Ann Arbor, Michigan, 48109, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55454, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
University of Wisconsin-Madison CF Center
Madison, Wisconsin, 53792, United States
Biospecimen
Sweat samples will be collected per standard sweat testing procedure.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Rock, MD
University of Wisconsin, Madison
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2015
First Posted
March 31, 2015
Study Start
February 8, 2017
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
August 31, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share