Cystic FibrosisCHEC-SCNCT03350828
CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
An observational study of Cystic Fibrosis, run by Nicole Hamblett at 52 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 months and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 5,000 participants
- Where
- 52 sitesUnited States
- Study dates
- 15 Jan 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cystic Fibrosis Care Centers
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
- 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)
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
United States52 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta and Emory University
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30327
Children's Hospital Colorado
Aurora, Colorado, 80045
John Hopkins Hospital
Baltimore, Maryland, 21287
The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
The Cystic Fibrosis Center of Western New York
Buffalo, New York, 14203
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517
Medical University of South Carolina
Charleston, South Carolina, 29425
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern / Children's Health
Dallas, Texas, 75207
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Children's Hospital of Michigan
Detroit, Michigan, 48201
University of Florida
Gainesville, Florida, 32610
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
Children's Mercy Kansas City
Kansas City, Missouri, 64108
University of California San Diego
La Jolla, California, 92093
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky
Lexington, Kentucky, 40506
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Childrens Hospital Los Angeles
Los Angeles, California, 90027
University of Wisconsin
Madison, Wisconsin, 53792
University of Tennessee CF Care and Research Center
Memphis, Tennessee, 38103
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, 55455
West Virginia University - Morgantown
Morgantown, West Virginia, 26506
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06520
The Nemours Children's Clinic - Orlando
Orlando, Florida, 32827
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32514
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Oregon Health Sciences University
Portland, Oregon, 97239
Primary Children's Cystic Fibrosis Center
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
University of Washington Medical Center
Seattle, Washington, 98195
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
St. Louis Children's Hospital
St Louis, Missouri, 63110
Toledo Children's Hospital
Toledo, Ohio, 43606
New York Medical College at Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
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.
Read the detailed description
Eligible subjects who have been prescribed and chronically taking a commercially approved CFTR modulator for at least 3 months will be enrolled for a single visit to collect sweat to be analyzed for SC at their local site laboratory. Limited clinical data obtained at this visit will be augmented by retrospective and prospective data obtained from the Cystic Fibrosis Foundation Patient Registry (CFFPR). Study subjects who have been prescribed and switch to an alternative commercially approved CFTR modulator will be approached to re-enroll in the study after being on the alternative modulator for at least 3 months so that a new SC value can be obtained.
- Conditions
- Cystic Fibrosis
- Keywords
- CF, Cystic Fibrosis, Sweat, Sweat chloride, CFTR Modulator
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change in sweat chloride pre- to post- modulator therapy
mean change in sweat chloride pre- to post- modulator therapy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start15 Jan 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicole Hamblett
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor-investigator, Nicole Hamblett, Seattle Children's Hospital
- Investigators
- Edith Zemanick, MD, Principal investigator, University of Colorado, DenverMichael Konstan, MD, Principal investigator, Case Western Reserve UniversityNicole Mayer-Hamblett, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350828
- Sponsor's protocol ID
- CHEC-OB-17
- Acronym
- CHEC-SC
- Status last verified
- Oct 2025
- First submitted
- 9 Nov 2017
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
VanDevanter DR, Zemanick ET, Konstan MW, Ren CL, Odem-Davis K, Emerman I, Young J, Mayer-Hamblett N; CHEC-SC Study Group. Willingness of people with cystic fibrosis receiving elexacaftor/tezacaftor/ivacaftor (ETI) to participate in randomized modulator and inhaled antimicrobial clinical trials. J Cyst Fibros. 2023 Jul;22(4):652-655. doi: 10.1016/j.jcf.2023.04.007. Epub 2023 Apr 24.
PubMed 37100705
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03350828
- Acronym / sponsor ID
- CHEC-SC / CHEC-OB-17
- Conditions
- Cystic Fibrosis
- Keywords
- CF, Cystic Fibrosis, Sweat, Sweat chloride, CFTR Modulator
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Nicole HamblettUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible subjects who have been prescribed and chronically taking a commercially approved CFTR modulator for at least 3 months will be enrolled for a single visit to collect sweat to be analyzed for SC at their local site laboratory. Limited clinical data obtained at this visit will be augmented by retrospective and prospective data obtained from the Cystic Fibrosis Foundation Patient Registry (CFFPR). Study subjects who have been prescribed and switch to an alternative commercially approved CFTR modulator will be approached to re-enroll in the study after being on the alternative modulator for at least 3 months so that a new SC value can be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cystic Fibrosis Care Centers
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mean change in sweat chloride pre- to post- modulator therapy
Time frame: through study completion, an average of 1 year
mean change in sweat chloride pre- to post- modulator therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Derived from this study: PubMed 37100705VanDevanter DR, Zemanick ET, Konstan MW, Ren CL, Odem-Davis K, Emerman I, Young J, Mayer-Hamblett N; CHEC-SC Study Group. Willingness of people with cystic fibrosis receiving elexacaftor/tezacaftor/ivacaftor (ETI) to participate in randomized modulator and inhaled antimicrobial clinical trials. J Cyst Fibros. 2023 Jul;22(4):652-655. doi: 10.1016/j.jcf.2023.04.007. Epub 2023 Apr 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edith Zemanick, MD principal investigator
University of Colorado, Denver
Michael Konstan, MD principal investigator
Case Western Reserve University
Nicole Mayer-Hamblett, PhD principal investigator
Seattle Children's Hospital
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Nicole Hamblett at 52 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean change in sweat chloride pre- to post- modulator therapy (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03350828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.