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.
Key facts
- Who runs it
- Ain Shams University
- Where
- Cairo, EgyptSee the site
- Trial code
- Registry title
- Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic Fibrosis Patients
- Status
- Recruiting
- People taking part
- 35 people, planned
- Started
- 7 Oct 2024
- Planned end
- 12 Dec 2025
- Type of study
- Observational
- Record updated
- 8 April 2025
Who can take part
AI summary
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)
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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%
Who cannot take part
- ●Patients are unable to perform spirometry
Where in Egypt
- Ain Shams UniversityCairo, EgyptContact: Ain Shams university Ain Shams university, MDTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Pediatric CF patients aged 6 years and above with an FEV₁% predicted below 80%.
Using quality improvement principles for patient care and reassessing after one year.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Serum Human Epididymis Protein 4 and Pulmonary Function Before and After Structural Quality Improvement Protocol Among Cystic Fibrosis Patients
- Plain-language title
- Measuring a blood marker and lung function in people with cystic fibrosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 8 April 2025