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
- Diseases
- Cystic fibrosis
- 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
Sites (52)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Medical Center of Akron Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| University of Michigan - Michigan Medicine Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Healthcare of Atlanta and Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| John Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| The Children's Hospital Alabama & University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The Cystic Fibrosis Center of Western New York Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Texas Southwestern, Children's Health Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Children's Hospital of Michigan Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Hershey Medical Center Pennsylvania State University Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Children's Mercy Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Childrens Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| University of Tennessee CF Care and Research Center Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Children's Hospital of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| The Minnesota Cystic Fibrosis Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| West Virginia University - Morgantown Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Vanderbilt Children's Hospital Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| The Nemours Children's Clinic - Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Nemours Children's Clinic - Pensacola Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Oregon Health Sciences University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Primary Children's Cystic Fibrosis Center Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| SSM Health Cardinal Glennon Children's Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| St. Louis Children's Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Toledo Children's Hospital Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| New York Medical College at Westchester Medical Center Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.