NCT06915961 Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic Fibrosis Patients
| NCT ID | NCT06915961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ain Shams University |
| Condition | Cystic Fibrosis (CF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-10-07 |
| Primary Completion | 2025-10-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35 participants in total. It began in 2024-10-07 with a primary completion date of 2025-10-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Eman Fawzy
PRINCIPAL INVESTIGATOR
Ain Shams University
Frequently Asked Questions
Who can join the NCT06915961 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Cystic Fibrosis (CF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06915961 currently recruiting?
Yes, NCT06915961 is actively recruiting participants. Contact the research team at eman199358@gmail.com for enrollment information.
Where is the NCT06915961 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06915961 clinical trial?
NCT06915961 is sponsored by Ain Shams University. The principal investigator is Eman Fawzy at Ain Shams University. The trial plans to enroll 35 participants.