NCT07599969 Bronchiectasis Phenotype Identification Model
| NCT ID | NCT07599969 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assiut University |
| Condition | Bronchiectasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2026-11-01 |
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 750 participants in total. It began in 2025-09-11 with a primary completion date of 2026-11-01.
⚠ 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
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.
Eligibility Criteria
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 assessment. * Inability to complete required baseline disease-signature assessment according to the Bronchiectasis Phenotype Identification Model (BPIM) protocol. * Inability or unwillingness to complete planned longitudinal follow-up. * Refusal to participate.
Contact & Investigator
Ahmad M Shaddad, MD
PRINCIPAL INVESTIGATOR
Assiut University
Frequently Asked Questions
Who can join the NCT07599969 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bronchiectasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07599969 currently recruiting?
Yes, NCT07599969 is actively recruiting participants. Contact the research team at shaddad_ahmad@aun.edu.eg for enrollment information.
Where is the NCT07599969 trial being conducted?
This trial is being conducted at Asyut, Egypt.
Who is sponsoring the NCT07599969 clinical trial?
NCT07599969 is sponsored by Assiut University. The principal investigator is Ahmad M Shaddad, MD at Assiut University. The trial plans to enroll 750 participants.