The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and their Association with Clinical Outcomes (the CHEC-SC study)

Study on Sweat Chloride Levels in Cystic Fibrosis Patients Using Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators

D
Don Sanders, MD

Primary Investigator

Enrolling By Invitation
4 months or above
All
Phase N/A
3 Locations

Brief description of study

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.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cystic Fibrosis, Riley
  • Age: 4 months or above
  • Gender: All

Inclusion Criteria:

  1. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
  2. Enrolled in the CFFPR
  3. Male or female ≥ 4 months of age on day of study visit
  4. Diagnosis of CF.
  5. Current treatment with a prescribed commercially approved CFTR modulator for at least 90 days prior to enrollment
  6. Able to perform the testing and procedures required for this study, as judged by the investigator

Additional Inclusion Criteria for CHEC-PKPD Sub-Study:

  1. Male or female ≥ 6 years of age on day of study visit.
  2. Current treatment with elexacaftor/tezacaftor/ivacaftor for at least 90 days prior to enrollment.
  3. 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.

Exclusion Criteria:

  1. 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
  2. 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)
     

This study investigates how treatments for Cystic Fibrosis affect sweat chloride levels. Cystic Fibrosis is a condition that causes thick mucus to build up in the lungs and other parts of the body. This study is looking at people who are taking certain medicines called CFTR modulators, which help improve the function of a protein that is faulty in people with Cystic Fibrosis.

Participants will have their sweat tested to measure chloride levels. This involves a single visit where sweat is collected and analyzed. Some information will also be gathered from a patient registry to help understand the effects of the treatment over time.

  • Who can participate: People aged 4 months and older with Cystic Fibrosis who have been taking CFTR modulators for at least 90 days can participate. Participants must be enrolled in the Cystic Fibrosis Foundation Patient Registry and able to perform study procedures.
  • Study details: Participants will visit once to have their sweat collected and analyzed. Those who switch CFTR modulators may be asked to return for another test after 3 months on the investigational medication.
  • Study visits: The study requires 1 visit.
Updated on 24 Sep 2025. Study ID: PPUL-CFFT-CHEC-SC, 1712442067
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only