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

History of Changes

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:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Sweat

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

U.S. FDA Resources

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


Ages Eligible for Study:	Child, Adult, Senior
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


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 Pancreatic Diseases Digestive System Diseases Lung Diseases	Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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