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NCT03350828Active, not recruiting

CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes

The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes

Source: ClinicalTrials.gov · Last updated 10 Oct 2025

Brief summary (registry, in English)

This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
5000 (estimated)
First submitted
9 Nov 2017
Start date
15 Jan 2018
Primary completion date
31 Dec 2026
Lead sponsor
Nicole Hamblett
NCT number
NCT03350828

What you commit to

  • Study type: Observational
  • Planned participants: 5000
  • From 15 Jan 2018 to the primary completion date, 31 Dec 2026
  • 52 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data

Other

  • Currently enrolled in an investigational trial (including open-label follow-on studies and Early Access Programs (EAP) of an agent expected to have an impact on sweat chloride (refer to current list provided on study website)

Who the study is looking for

  • Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
  • Enrolled in the CFFPR
  • Male or female ≥ 4 months of age on day of study visit
  • Diagnosis of CF.
  • Current treatment with a prescribed commercially approved CFTR modulator for at least 90 days prior to enrollment
  • Able to perform the testing and procedures required for this study, as judged by the investigator
    • Additional Inclusion Criteria for CHEC-PKPD Sub-Study:
  • Male or female ≥ 6 years of age on day of study visit.
  • Current treatment with elexacaftor/tezacaftor/ivacaftor for at least 90 days prior to enrollment.
  • Last dose of elexacaftor/tezacaftor/ivacaftor taken at least 24hours and last dose of ivacaftor taken at least 12 hours prior to trough blood draw on day of visit.

Age in the registry: 4 months to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (52)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Hospital Medical Center of Akron
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AkronUnited StatesUnknown status
University of Michigan - Michigan Medicine
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Ann ArborUnited StatesUnknown status
Emory University
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AtlantaUnited StatesUnknown status
Children's Healthcare of Atlanta and Emory University
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AtlantaUnited StatesUnknown status
Children's Hospital Colorado
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AuroraUnited StatesUnknown status
John Hopkins Hospital
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BaltimoreUnited StatesUnknown status
The Children's Hospital Alabama & University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Boston Children's Hospital
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BostonUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
The Cystic Fibrosis Center of Western New York
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BuffaloUnited StatesUnknown status
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Ann & Robert H. Lurie Children's Hospital of Chicago
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ChicagoUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center
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ClevelandUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
University of Texas Southwestern, Children's Health
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DallasUnited StatesUnknown status
National Jewish Health
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DenverUnited StatesUnknown status
Children's Hospital of Michigan
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DetroitUnited StatesUnknown status
University of Florida
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GainesvilleUnited StatesUnknown status
Helen DeVos Children's Hospital
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Grand RapidsUnited StatesUnknown status
Hershey Medical Center Pennsylvania State University
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HersheyUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
Riley Hospital for Children
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IndianapolisUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
Children's Mercy Kansas City
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Kansas CityUnited StatesUnknown status
University of California San Diego
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La JollaUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
University of Kentucky
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LexingtonUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Childrens Hospital Los Angeles
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Los AngelesUnited StatesUnknown status
University of Wisconsin
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MadisonUnited StatesUnknown status
University of Tennessee CF Care and Research Center
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MemphisUnited StatesUnknown status
Children's Hospital of Wisconsin
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MilwaukeeUnited StatesUnknown status
The Minnesota Cystic Fibrosis Center
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MinneapolisUnited StatesUnknown status
West Virginia University - Morgantown
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MorgantownUnited StatesUnknown status
Vanderbilt Children's Hospital
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NashvilleUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
The Nemours Children's Clinic - Orlando
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OrlandoUnited StatesUnknown status
Nemours Children's Clinic - Pensacola
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PensacolaUnited StatesUnknown status
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesUnknown status
Children's Hospital of Pittsburgh of UPMC
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PittsburghUnited StatesUnknown status
Oregon Health Sciences University
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PortlandUnited StatesUnknown status
Primary Children's Cystic Fibrosis Center
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Salt Lake CityUnited StatesUnknown status
University of Washington Medical Center
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SeattleUnited StatesUnknown status
Seattle Children's Hospital
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SeattleUnited StatesUnknown status
SSM Health Cardinal Glennon Children's Hospital
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St LouisUnited StatesUnknown status
St. Louis Children's Hospital
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St LouisUnited StatesUnknown status
Toledo Children's Hospital
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ToledoUnited StatesUnknown status
New York Medical College at Westchester Medical Center
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ValhallaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.