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BPIM: Bronchiectasis Phenotype Identification Model for Supervised Baseline Translation of Latent Class Trajectory Analysis-Derived Phenotypes in Non-Cystic Fibrosis Bronchiectasis

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Assiut university-Faculty of Medicine
RECRUITING
Asyut
Contact Information
Primary
Ahmad M Shaddad, MD
shaddad_ahmad@aun.edu.eg
+201111171930
Time Frame
Start Date: 2025-09-11
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 750
Treatments
Development Cohort
Adults with clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB) assigned to the analytical development cohort. This cohort will be used to execute the prespecified latent class trajectory analysis (LCTA) hierarchy, identify the accepted trajectory-derived phenotype structure, assign phenotype labels according to the locked convention, and train the supervised Bronchiectasis Phenotype Identification Model (BPIM) classifier using the locked baseline disease-signature architecture. No treatment, medication, intervention, exposure, or management strategy is assigned by the study protocol.
Validation Cohort
Adults with clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB) assigned to the analytical validation cohort. This cohort will be used only to evaluate the locked Bronchiectasis Phenotype Identification Model (BPIM) classifier after training in the development cohort. No validation-stage refitting, recalibration, predictor substitution, phenotype relabeling, threshold retuning, or post hoc classifier rescue will be performed. No treatment, medication, intervention, exposure, or management strategy is assigned by the study protocol.
Related Therapeutic Areas
Sponsors
Leads: Assiut University

This content was sourced from clinicaltrials.gov