A Study of Sweat Testing Using a Quantitative Patch

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Polychrome Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01345617
First received: April 28, 2011
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Study of Sweat Testing Using a Quantitative Patch

Resource links provided by NLM:


Further study details as provided by Polychrome Medical, Inc.:

Primary Outcome Measures:
  • sweat chloride value [ Time Frame: once, at enrollment (baseline) ] [ Designated as safety issue: No ]
    Sweat chloride measurements obtained by GCQPIT and CFQT


Secondary Outcome Measures:
  • QNS rate [ Time Frame: once, at enrollment (baseline) ] [ Designated as safety issue: No ]
    QNS rate of CFQT compared to GCQPIT


Enrollment: 170
Study Start Date: January 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
cystic fibrosis patients
cystic fibrosis patients
non-cystic fibrosis patients
non-cystic fibrosis patients

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

pediatric pulmonology clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345617

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84012
United States, Wisconsin
American Family Children's Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Polychrome Medical, Inc.
Investigators
Principal Investigator: Michael J Rock, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Polychrome Medical, Inc.
ClinicalTrials.gov Identifier: NCT01345617     History of Changes
Other Study ID Numbers: 2011-0291, CFQuantum001
Study First Received: April 28, 2011
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014