Bronchiectasis Phenotype Identification Model (NCT07599969) | Clinical Trial Compass
RecruitingNot Applicable
Bronchiectasis Phenotype Identification Model
Egypt750 participantsStarted 2025-09-11
Plain-language summary
The Bronchiectasis Phenotype Identification Model (BPIM) is a prospective observational development-validation study within the Assiut University bronchiectasis translational research platform.
The study evaluates whether latent class trajectory analysis (LCTA)-derived bronchiectasis phenotype classes can be translated into a supervised baseline classifier for adults with non-cystic fibrosis bronchiectasis (NCFB).
Latent class trajectory analysis (LCTA) will first identify trajectory-derived phenotype classes using prospectively collected longitudinal disease-signature data. The Bronchiectasis Phenotype Identification Model (BPIM) will then be trained to predict the accepted latent class trajectory analysis (LCTA)-derived phenotype class using the locked baseline disease-signature architecture.
This study is observational and non-interventional. No treatment, medication, intervention, exposure, or management strategy is assigned by the protocol. All participants receive routine clinical care according to institutional practice and treating physician judgment.
The locked methodological disclosure, protocol, and deterministic statistical analysis plan are archived in the version-specific Zenodo record: https://doi.org/10.5281/zenodo.20157926.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients aged 18 years or older.
* Diagnosis of non-cystic fibrosis bronchiectasis (NCFB) based on clinical assessment and high-resolution computed tomography (HRCT).
* Patients attending outpatient clinics, inpatient wards, or respiratory follow-up services at Assiut University Hospitals during the study enrollment period.
* Patients suitable for baseline disease-signature assessment within the Bronchiectasis Phenotype Identification Model (BPIM) framework.
* Ability to undergo routine clinical, functional, radiological, oxygenation, and inflammatory assessment according to the study protocol.
* Ability to complete planned longitudinal follow-up required for latent class trajectory analysis (LCTA) and Bronchiectasis Phenotype Identification Model (BPIM) validation.
* Written informed consent obtained from the patient or legal representative.
Exclusion Criteria:
* Cystic fibrosis-related bronchiectasis.
* Traction bronchiectasis due to advanced fibrotic interstitial lung disease as the dominant respiratory diagnosis.
* Active pulmonary tuberculosis at enrollment.
* Active nontuberculous mycobacterial pulmonary disease requiring specific treatment at enrollment.
* Active malignancy or terminal non-respiratory illness expected to prevent planned follow-up.
* Acute life-threatening illness preventing safe enrollment or reliable baseline assessment.
* Recent major thoracic surgery or acute thoracic trauma interfering with baseline respiratory assess…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Validation Classification Accuracy of the Bronchiectasis Phenotype Identification Model (BPIM) for Latent Class Trajectory Analysis-Derived Phenotype Classes