Cystic Fibrosis (CF)NCT06915961
Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic Fibrosis Patients
An observational study of Cystic Fibrosis (CF), run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis (CF)
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Oct 2024to 12 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will be conducted on 35 children diagnosed with cystic fibrosis, patients will be between the age of 6 years and 18 years old, and they will be selected during their follow-up visits to Pediatric Chest Clinic, Ain Shams University Hospital.
Who may be able to join
- 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 join
- ●Patients are unable to perform spirometry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams university
Cairo, Abbasia, 00202
Ain Shams university Ain Shams university, MD, 01011778583, EMANABDELNAEEM@MED.ASU.EDU.EG
Eman Fawzy, MD
About this study
Official title: 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.
Read the detailed description
This study will be conducted on 35 children diagnosed with cystic fibrosis, aged between 6 and 18 years. Patients will be selected during their follow-up visits to the Pediatric Chest Clinic at Ain Shams University Hospital.
Inclusion Criteria:
- Pediatric cystic fibrosis 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 cystic fibrosis disease-causing gene mutations.
- Age ≥6 years. C. Forced expiratory volume in 1st second (FEV₁) ≤80%.
Exclusion Criteria:
- Patients unable to perform spirometry.
All subjects in the study will undergo an interventional quality improvement plan.
A specialized clinic for CF patients will be established based on the quality improvement (QI) plan, where patients will be followed up every three months by a specialized multidisciplinary team, including a pediatric pulmonologist, pediatric nutrition consultant, pediatric gastroenterologist, chest physiotherapist, and pediatric endocrinologist.
Each specialized clinic will develop and implement standardized cystic fibrosis care algorithms and individualized treatment plans for each patient. These algorithms and plans will be continuously adjusted based on challenges encountered during follow-up to address barriers and deficiencies that may contribute to poor outcomes.
Areas needing improvement will be identified, and appropriate resources and strategies will be proposed. This will include the development of fishbone diagrams, flowcharts, Plan-Do-Study-Act (PDSA) cycles, PDSA ramps, and other quality improvement tools to address specific deficiencies. Additionally, training and engaging the team in quality improvement methodologies will be conducted.
Patients will undergo pulmonary function tests at baseline, followed by assessments at six months and one year during the study.
- Conditions
- Cystic Fibrosis (CF)
- Keywords
- Quality Improvement (QI)
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Improvement Protocol for Achieving a 5% Increase in FEV₁% Predicted Value in CF Patients"
Implementation of a quality improvement protocol to achieve a 5% increase in the FEV₁% predicted value in cystic fibrosis patients with impaired pulmonary function. Pulmonary function will be assessed using spirometry at baseline, six months, and 12 months.
Measured: 12 months
Secondary outcomes (1)
Serum HE4 Levels Before and After Pulmonary Function Improvement
Measurement of HE4 levels in the serum of studied subjects before and after pulmonary function improvement. HE4 levels will be assessed using a standardized laboratory assay at baseline and after 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start7 Oct 2024
- Primary completion7 Oct 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eman Fawzy, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915961
- Sponsor's protocol ID
- FMASU MD267/2024
- Status last verified
- Feb 2025
- First submitted
- 6 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Human Epididymis Protein 4 and Pulmonary Function Before and After Structural Quality Improvement Protocol Among Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT06915961
- Acronym / sponsor ID
- FMASU MD267/2024
- Conditions
- Cystic Fibrosis (CF)
- Keywords
- Quality Improvement (QI)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 7 Oct 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be conducted on 35 children diagnosed with cystic fibrosis, aged between 6 and 18 years. Patients will be selected during their follow-up visits to the Pediatric Chest Clinic at Ain Shams University Hospital.
Inclusion Criteria:
- Pediatric cystic fibrosis 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 cystic fibrosis disease-causing gene mutations.
- Age ≥6 years. C. Forced expiratory volume in 1st second (FEV₁) ≤80%.
Exclusion Criteria:
- Patients unable to perform spirometry.
All subjects in the study will undergo an interventional quality improvement plan.
A specialized clinic for CF patients will be established based on the quality improvement (QI) plan, where patients will be followed up every three months by a specialized multidisciplinary team, including a pediatric pulmonologist, pediatric nutrition consultant, pediatric gastroenterologist, chest physiotherapist, and pediatric endocrinologist.
Each specialized clinic will develop and implement standardized cystic fibrosis care algorithms and individualized treatment plans for each patient. These algorithms and plans will be continuously adjusted based on challenges encountered during follow-up to address barriers and deficiencies that may contribute to poor outcomes.
Areas needing improvement will be identified, and appropriate resources and strategies will be proposed. This will include the development of fishbone diagrams, flowcharts, Plan-Do-Study-Act (PDSA) cycles, PDSA ramps, and other quality improvement tools to address specific deficiencies. Additionally, training and engaging the team in quality improvement methodologies will be conducted.
Patients will undergo pulmonary function tests at baseline, followed by assessments at six months and one year during the study.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be conducted on 35 children diagnosed with cystic fibrosis, patients will be between the age of 6 years and 18 years old, and they will be selected during their follow-up visits to Pediatric Chest Clinic, Ain Shams University Hospital.
Key inclusion criteria (3 listed)
- 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%.
Key exclusion criteria (1 listed)
- ●Patients are unable to perform spirometry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality Improvement Protocol for Achieving a 5% Increase in FEV₁% Predicted Value in CF Patients"
Time frame: 12 months
Implementation of a quality improvement protocol to achieve a 5% increase in the FEV₁% predicted value in cystic fibrosis patients with impaired pulmonary function. Pulmonary function will be assessed using spirometry at baseline, six months, and 12 months.
1 secondary outcome
Serum HE4 Levels Before and After Pulmonary Function Improvement
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eman Fawzy principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis (CF), run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman Fawzy, MD (Egypt: 201011778583, eman199358@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality Improvement Protocol for Achieving a 5% Increase in FEV₁% Predicted Value in CF Patients" (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.