Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT02869932
Eligibility Criteria:
Inclusion Criteria:
* Atypical CF cohort: children identified trough newborn screening on a hypertrypsinemia, who are older than 6 years of age at the time of inclusion and who carry a) 2 CFTR gene mutations of the CF30 kit with at least one R117H whatever the value of the sweat test or b) 2 CFTR gene mutations of the CF30 kit with a sweat test chloride \< 60mmol/L or c) 1 or 0 mutation in the CF30 kit with a sweat test ≥ 30 and \<60mmol/L and identification of additional mutations by comprehensive screening of the gene
* Classical CF cohort: children identified by newborn screening on a hypertrypsinemia, who are matched with an Atypical CF by age and sex if possible and who were diagnosed with a classical CF based on a sweat test \> 60 mmol/ L with 0, 1 or 2 CF causing gene mutations.
Exclusion Criteria:
* • Drugs such as CFTR modulators interfering with the phenotypic expression of the disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
10 Years
Study:
NCT02869932
Study Brief:
Protocol Section:
NCT02869932