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

Investigation of Sweat Chloride Levels in Cystic Fibrosis Patients

Recruiting
1 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

This study will collect contemporary sweat chloride values from cystic fibrosis patients prescribed and currently receiving commercially approved CFTR modulator therapies.

Detailed description of study

This is a multicenter, cross-sectional, cohort study which will collect contemporary SC values from approximately 1000 CF patients prescribed and currently receiving commercially approved CFTR modulator therapies.
Participants will not be paid for their participation.

Eligibility of study

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

  • Conditions: cystic fibrosis
  • Age: 1 years - 100 years
  • Gender: All

Inclusion Criteria
Documentation of a CF diagnosis
Current treatment with a prescribed commercially approved CFTR modulator for at least 3 months prior to enrollment
Exclusion Criteria
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 EAPs) of an agent expected to have an impact on sweat chloride

Updated on 19 Feb 2024. Study ID: 1712442067

The purpose of this study is to investigate sweat chloride levels in patients with cystic fibrosis who are currently taking CFTR modulator therapies. Cystic fibrosis is a genetic condition that affects the lungs and digestive system, leading to the production of thick, sticky mucus. CFTR modulators are medications that help improve the function of the defective protein in cystic fibrosis patients.

Participants in this study will have their sweat chloride levels measured. Sweat chloride testing is a method used to diagnose cystic fibrosis and monitor treatment effectiveness. This study will involve collecting sweat samples from about 1000 patients who are taking CFTR modulators.

  • Who can participate: Individuals diagnosed with cystic fibrosis who have been on a prescribed CFTR modulator treatment for at least 3 months can participate. Participants must not be involved in any other investigational trials that might influence sweat chloride levels.
  • Study details: Participants will provide sweat samples for testing. The study will measure sweat chloride levels to understand the impact of CFTR modulators. No placebo is involved in this study.

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