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NCT03350828: CHEC-SC

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

Active, enrolled Last updated 10 October 2025
What this trial tests

trial in Cystic Fibrosis in 5,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
15 January 2018
Primary endpoint
31 December 2026
31 December 2026

Quick facts

Lead sponsorNicole Hamblett
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment5,000
Start date15 January 2018
Primary completion31 December 2026
Estimated completion31 December 2026
Sites52 locations across United States

Conditions studied

Sponsor

Nicole Hamblett

Who can join

4 Months and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. PROMISE: Working with the CF community to understand emerging clinical and research needs for those treated with highly effective CFTR modulator therapy.
    Nichols DP, Donaldson SH, Frederick CA, Freedman SD, et al · · 2021 · cited 68× · PMID 33619012 · DOI 10.1016/j.jcf.2021.02.003
  2. Heterogeneity of CFTR modulator-induced sweat chloride concentrations in people with cystic fibrosis.
    Zemanick ET, Emerman I, McCreary M, Mayer-Hamblett N, et al · · 2024 · cited 18× · PMID 38360461 · DOI 10.1016/j.jcf.2024.02.001
  3. Measuring the impact of CFTR modulation on sweat chloride in cystic fibrosis: Rationale and design of the CHEC-SC study.
    Zemanick ET, Konstan MW, VanDevanter DR, Rowe SM, et al · · 2021 · cited 16× · PMID 33573995 · DOI 10.1016/j.jcf.2021.01.011
  4. Characterizing CFTR modulated sweat chloride response across the cf population: Initial results from the CHEC-SC study.
    Mayer-Hamblett N, Zemanick ET, Odem-Davis K, VanDevanter D, et al · · 2023 · cited 7× · PMID 35871974 · DOI 10.1016/j.jcf.2022.07.008
  5. Willingness of people with cystic fibrosis receiving elexacaftor/tezacaftor/ivacaftor (ETI) to participate in randomized modulator and inhaled antimicrobial clinical trials.
    VanDevanter DR, Zemanick ET, Konstan MW, Ren CL, et al · · 2023 · cited 4× · PMID 37100705 · DOI 10.1016/j.jcf.2023.04.007
  6. Impact of CFTR Modulator Concentrations on Clinical Response in Cystic Fibrosis.
    Chalamalla AR, Baker E, Ryan KJ, Dowell A, et al · · 2026 · PMID 41713946 · DOI 10.1183/13993003.01594-2025

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Other recruiting trials for Cystic Fibrosis

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Data sources for this page

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