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

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.

Study Overview

• Status: Terminated
• Conditions: Cystic Fibrosis
• Intervention / Treatment: 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
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's Hospital of Alabama at UAB
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital of Chicago
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan-Ann Arbor, Cystic Fibrosis Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Masonic Children's Hospital
  • Ohio
    • Dayton, Ohio, United States, 45404
      • Dayton Children's Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin-Madison CF Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Polychrome Medical, Inc.
• Investigators: Principal Investigator: Michael Rock, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2017
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis
• Other Study ID Numbers: CFQuantum003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes