Measuring a blood marker and lung function in people with cystic fibrosis
Measures a blood marker, HE4, and lung function in people with cystic fibrosis.
Plain-language title generated from the registry record
Registry title: Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic Fibrosis Patients
Key facts
- Where
- Cairo, EgyptSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with cystic fibrosis (CF) whose lung function is reduced. It tests a quality improvement plan to raise lung function over 12 months.
- Age
- 6 years or older
- Sex
- All sexes
- Disease stage
- Reduced lung function: FEV₁ of 80% or less
- Biomarker or test result
- CF confirmed by a positive sweat chloride test (60 milliequivalent/L or more) and/or two CF disease-causing gene mutations
Main reasons for not taking part
- Cannot do spirometry (a lung function breathing test)
Read by machine on 9 November 2026.
Where in Egypt
- Ain Shams UniversityCairo, EgyptTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ain Shams University
- Trial code
- NCT06915961
- Record updated
- 8 April 2025
- Original description
To implement a quality improvement plan aimed at achieving a 5% increase in the Forced expiratory volume in 1st second (FEV1) (% predicted value) in cystic fibrosis (CF) patients with impaired pulmonary function parameters over 12 months. Additionally, the plan aims to measure serum human epididymis protein 4 (HE4) levels in the studied subjects before and after pulmonary function improvement.Read full original descriptionShow less
Serum Human Epididymis Protein 4 and Pulmonary Function Before and After Structural Quality Improvement Protocol Among Cystic Fibrosis Patients
To implement a quality improvement plan aimed at achieving a 5% increase in the Forced expiratory volume in 1st second (FEV1) (% predicted value) in cystic fibrosis (CF) patients with impaired pulmonary function parameters over 12 months. Additionally, the plan aims to measure serum human epididymis protein 4 (HE4) levels in the studied subjects before and after pulmonary function improvement.
Inclusion: Pediatric CF patients diagnosed based on the Consensus Guidelines from the Cystic Fibrosis Foundation, with a positive sweat chloride test (≥60 milliequivalent/L) and/or the presence of two CF disease-causing gene mutations; Age ≥6 years; Forced expiratory volume in 1 second (FEV₁) ≤80%.
Exclusion: ●Patients are unable to perform spirometry.