Non-cystic Fibrosis BronchiectasisNCT06352944
Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children
An observational study of Non-cystic Fibrosis Bronchiectasis, run by Assiut University.
Trial summary
The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers (functional and radiological severity ) Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- procalcitonin
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged from 6 to 18 years diagnosed with Non-cystic fibrosis bronchiectasis
Who may be able to join
- Children of both sex
- Children aged from 6-17 years old.
- Documented diagnosis of non-CF bronchiectasis by confirmed bronchiectasis findings using high-resolution computed tomographic (HRCT) lung scanning, and clinical symptoms consistent with bronchiectasis with a negative sweat test
Who cannot join
- Age less than 6 years or more than 17 years.
- Children Diagnosed with cystic fibrosis bronchiectasis with confirmed positive sweat chloride test(6).
- If there was a history of a recent exacerbation during the previous month preceding the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bronchoscopic Derived Bronchoalveolar Lavage Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children
The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers (functional and radiological severity )
Read the detailed description
- The severity of bronchiectasis will be assessed using forced expiratory volume in 1s (FEV1), and bronchiectasis severity scores which included bronchiectasis severity index (BSI) , FEV1, chronic colonization, extension of lobes and dyspnea which were performed to assess non-CF bronchiectasis patients.
BSI score
- This score incorporates 9 variables. The total score is calculated by summing the scores for each variable and can range from 0 to 26 points. According to the overall score, patients are classified into three classes: patients with low BSI score (0---4 points), intermediate BSI score (5---8 points), high BSI score (≥9 points)
- chest X ray and HRCT of the chest: to assess the radiological severity of bronchiectasis using the radiological findings will be measured by assessing the most recent chest X ray and HRCT of the chest performed in the last six months using Bhalla score(10)
- Culture and sensitivity from bronchoalveolar lavage for isolation of pseudomonas aeruginosa and any other organism.
- Sputum procalcitonin level was measured in BAL samples using bronchoscopy.
- Bronchoscopy: would be undertaken when the children were in a stable clinical condition as part of their annual review
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- procalcitonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitoninDiagnostic test
level of procalcitonin in bronchoalveolar lavage
What is being measured
The primary outcome is the main question the study is designed to answer.
procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children
comparison between procalcitonin level in Bronchoalveolar lavage and other markers of severity of bronchiectasis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Mohamed Amir Fathy, Assiut University
- Investigators
- Yasser F abdelrahem, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352944
- Sponsor's protocol ID
- AssiutMD
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Derived Bronchoalveolar Lavage Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children
- ClinicalTrials.gov ID
- NCT06352944
- Acronym / sponsor ID
- AssiutMD
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Apr 2024 (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.
The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers (functional and radiological severity )
Detailed description
- The severity of bronchiectasis will be assessed using forced expiratory volume in 1s (FEV1), and bronchiectasis severity scores which included bronchiectasis severity index (BSI) , FEV1, chronic colonization, extension of lobes and dyspnea which were performed to assess non-CF bronchiectasis patients.
BSI score
- This score incorporates 9 variables. The total score is calculated by summing the scores for each variable and can range from 0 to 26 points. According to the overall score, patients are classified into three classes: patients with low BSI score (0---4 points), intermediate BSI score (5---8 points), high BSI score (≥9 points)
- chest X ray and HRCT of the chest: to assess the radiological severity of bronchiectasis using the radiological findings will be measured by assessing the most recent chest X ray and HRCT of the chest performed in the last six months using Bhalla score(10)
- Culture and sensitivity from bronchoalveolar lavage for isolation of pseudomonas aeruginosa and any other organism.
- Sputum procalcitonin level was measured in BAL samples using bronchoscopy.
- Bronchoscopy: would be undertaken when the children were in a stable clinical condition as part of their annual review
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged from 6 to 18 years diagnosed with Non-cystic fibrosis bronchiectasis
Key inclusion criteria (3 listed)
- Children of both sex
- Children aged from 6-17 years old.
- Documented diagnosis of non-CF bronchiectasis by confirmed bronchiectasis findings using high-resolution computed tomographic (HRCT) lung scanning, and clinical symptoms consistent with bronchiectasis with a negative sweat test
Key exclusion criteria (3 listed)
- Age less than 6 years or more than 17 years.
- Children Diagnosed with cystic fibrosis bronchiectasis with confirmed positive sweat chloride test(6).
- If there was a history of a recent exacerbation during the previous month preceding the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| procalcitoninlevel of procalcitonin in bronchoalveolar lavage | Diagnostic test | – |
Primary outcome
procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children
Time frame: 2 years
comparison between procalcitonin level in Bronchoalveolar lavage and other markers of severity of bronchiectasis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yasser F abdelrahem, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Non-cystic Fibrosis Bronchiectasis, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact maram M amir, lecturer (01014808876, maramamir1994@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children (time frame: 2 years). 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 17 Apr 2024.