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A Multi-Center Study of the CF Quantum® Sweat Test System

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ClinicalTrials.gov Identifier: NCT02404714
Recruitment Status : Terminated (Study funding has been withdrawn. No adverse safety issues.)
First Posted : March 31, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Polychrome Medical, Inc.

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.

Condition or disease Intervention/treatment
Cystic Fibrosis Device: Iontophoresis sweat test

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 Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Multi-Center Study of A New Method of Sweat Testing: The CF Quantum® Sweat Test
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Device: Iontophoresis sweat test
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.

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.

Device: Iontophoresis sweat test
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.




Primary Outcome Measures :
  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 [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Compare the sweat test's "quantity not sufficient" (QNS) rate of the new device to the standard-of-care device. [ Time Frame: Day 1 ]

Biospecimen Retention:   Samples Without DNA
Sweat samples will be collected per standard sweat testing procedure.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Patients referred to the sweat test lab on a clinical basis.
  2. Infants who require a sweat test as follow-up to an abnormal CF screening test.
  3. Patients who have already been diagnosed with CF or CRMS.
  4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative.

Exclusion Criteria:

  1. Patient is receiving oxygen by open delivery.
  2. Infants less than 48 hours of age.
  3. Diffuse inflammation or rash on the collection site.
  4. Patients who have had a reaction to a prior iontophoretic sweat test procedure.
  5. Arm is too small for both the new and conventional sweat test.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404714


Locations
United States, Alabama
Children's Hospital of Alabama at UAB
Birmingham, Alabama, United States, 35233
United States, Illinois
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Michigan
University of Michigan-Ann Arbor, Cystic Fibrosis Center
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States, 55454
United States, Ohio
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
United States, Wisconsin
University of Wisconsin-Madison CF Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Polychrome Medical, Inc.
Investigators
Principal Investigator: Michael Rock, MD University of Wisconsin, Madison

Responsible Party: Polychrome Medical, Inc.
ClinicalTrials.gov Identifier: NCT02404714     History of Changes
Other Study ID Numbers: CFQuantum003
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases