CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
CHEC-SC
The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
1 other identifier
observational
5,000
1 country
52
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
52 active sites
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
November 9, 2017
CompletedFirst Posted
Study publicly available on registry
November 22, 2017
CompletedStudy Start
First participant enrolled
January 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 10, 2025
October 1, 2025
9 years
November 9, 2017
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mean change in sweat chloride pre- to post- modulator therapy
mean change in sweat chloride pre- to post- modulator therapy
through study completion, an average of 1 year
Eligibility Criteria
Cystic Fibrosis Care Centers
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nicole Hamblettlead
- Cystic Fibrosis Foundationcollaborator
Study Sites (52)
The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
University of California San Diego
La Jolla, California, 92093, United States
Childrens Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
University of Florida
Gainesville, Florida, 32610, United States
The Nemours Children's Clinic - Orlando
Orlando, Florida, 32827, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32514, United States
Children's Healthcare of Atlanta and Emory University
Atlanta, Georgia, 30322, United States
Emory University
Atlanta, Georgia, 30327, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
John Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, 55455, United States
Children's Mercy Kansas City
Kansas City, Missouri, 64108, United States
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
The Cystic Fibrosis Center of Western New York
Buffalo, New York, 14203, United States
New York Medical College at Westchester Medical Center
Valhalla, New York, 10595, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Tennessee CF Care and Research Center
Memphis, Tennessee, 38103, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232, United States
University of Texas Southwestern / Children's Health
Dallas, Texas, 75207, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Primary Children's Cystic Fibrosis Center
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
West Virginia University - Morgantown
Morgantown, West Virginia, 26506, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 37100705DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edith Zemanick, MD
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Michael Konstan, MD
Case Western Reserve University
- PRINCIPAL INVESTIGATOR
Nicole Mayer-Hamblett, PhD
Seattle Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor in the Department of Pediatrics in the Division of Pulmonary Medicine
Study Record Dates
First Submitted
November 9, 2017
First Posted
November 22, 2017
Study Start
January 15, 2018
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share