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Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic Fibrosis Patients

Recruitingn/aAges 6 Years - anyAllAin Shams University
NCT06915961 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: ●Patients are unable to perform spirometry.
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What it tests

  • Not listed
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Where

1 site
Ain Shams university
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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