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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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