Clinical trial NCT02404714: A Multi-Center Study of the CF Quantum® Sweat Test System
Official title: A Multi-Center Study of A New Method of Sweat Testing: The CF Quantum® Sweat Test
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cystic Fibrosis
Lead sponsor: Polychrome Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Day 1
Secondary outcomes:
measure: Compare the sweat test's "quantity not sufficient" (QNS) rate of the new device to the standard-of-care device.
timeFrame: Day 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama at UAB
state: Alabama
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan-Ann Arbor, Cystic Fibrosis Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Children's Hospital
state: Minnesota
city: Dayton
country: United States
facility: Dayton Children's Hospital
state: Ohio
city: Madison
country: United States
facility: University of Wisconsin-Madison CF Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael Rock, MD
role: PRINCIPAL_INVESTIGATOR
References: