A Study of Sweat Testing Using a Quantitative Patch

• ClinicalTrials.gov Identifier: NCT01345617
• Recruitment Status: Completed
• First Posted: May 2, 2011
• Last Update Posted: August 29, 2018
• Sponsor: Polychrome Medical, Inc.
• Information provided by (Responsible Party): Polychrome Medical, Inc.

Tracking Information

• First Submitted Date: April 28, 2011
• First Posted Date: May 2, 2011
• Last Update Posted Date: August 29, 2018
• Study Start Date: January 2012
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 29, 2011)

sweat chloride value [ Time Frame: once, at enrollment (baseline) ]

Sweat chloride measurements obtained by GCQPIT and CFQT

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 29, 2011)

QNS rate [ Time Frame: once, at enrollment (baseline) ]

QNS rate of CFQT compared to GCQPIT

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Sweat Testing Using a Quantitative Patch
• Official Title: A Study of Sweat Testing Using a Quantitative Patch
• Brief Summary: The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat chloride results that are equivalent to the results from traditional sweat testing. The secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum Sweat Test compared to traditional sweat testing.
• Detailed Description: All 50 states and the District of Columbia are performing newborn screening for cystic fibrosis (CF). Infants who have a positive newborn screen require follow-up with a sweat test. Gibson-Cooke Quantitative Pilocarpine Iontophoresis (GCQPIT) requires collecting sweat in microbore tubing or on gauze/filter paper and analyzing sweat using a chloridometer. This test has many difficulties including specimens that are quantity not sufficient (QNS), many steps of pipetting solutions in the laboratory, and the need for a chloridometer to analyze sweat chloride concentration. The only manufacturer of a chloridometer has ceased production of this instrument. The CF Quantum® Sweat Test System (CFQT) overcomes all of the difficulties of GCQPIT. This pilot study will determine if the CFQT provides results that are equivalent to GCQPIT.
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: pediatric pulmonology clinic
• Condition: Cystic Fibrosis
• Intervention: Not Provided

Study Groups/Cohorts

• cystic fibrosis patients
  cystic fibrosis patients
• non-cystic fibrosis patients
  non-cystic fibrosis patients

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 29, 2011): 170
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• clinical diagnosis of cystic fibrosis
• patients who require a sweat test

Exclusion Criteria:

• Infants less than 48 hours of age
• Patient is receiving oxygen by open delivery
• collection site has diffuse inflammation or rash

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Days and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01345617
• Other Study ID Numbers: 2011-0291; CFQuantum001 ( Other Identifier: PolyChrome Medical, Inc. )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Polychrome Medical, Inc.
• Original Responsible Party: Michael J. Rock, University of Wisconsin
• Current Study Sponsor: Polychrome Medical, Inc.
• Original Study Sponsor: University of Wisconsin, Madison
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael J Rock, MD; University of Wisconsin, Madison

• PRS Account: Polychrome Medical, Inc.
• Verification Date: August 2018