NCT01345617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

April 28, 2011

Last Update Submit

August 28, 2018

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • sweat chloride value

    Sweat chloride measurements obtained by GCQPIT and CFQT

    once, at enrollment (baseline)

Secondary Outcomes (1)

  • QNS rate

    once, at enrollment (baseline)

Study Arms (2)

cystic fibrosis patients

cystic fibrosis patients

non-cystic fibrosis patients

non-cystic fibrosis patients

Eligibility Criteria

Age2 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pediatric pulmonology clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Utah

Salt Lake City, Utah, 84012, United States

Location

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Michael J Rock, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2011

First Posted

May 2, 2011

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

US(3)