Bronchiectasis Phenotype Identification Model

NCT07599969 | Recruiting

• 2 other identifiers: 2026-5-4210.5281/zenodo.20157926
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis; Non-cystic Fibrosis Bronchiectasis; Bronchiectasis With Acute Exacerbation

Keywords

Non-cystic fibrosis bronchiectasis (NCFB); Bronchiectasis; Bronchiectasis Phenotype Identification Model (BPIM); Bronchiectasis exacerbation; Exacerbation risk; One-year exacerbation risk; Baseline risk prediction; Disease-signature model; Prospective observational cohort; Development-validation study; Latent class trajectory analysis (LCTA); supervised phenotype classifier

Outcome Measures

Primary Outcomes (1)

• Validation Classification Accuracy of the Bronchiectasis Phenotype Identification Model (BPIM) for Latent Class Trajectory Analysis-Derived Phenotype Classes

  Assessment of the validation performance of the Bronchiectasis Phenotype Identification Model (BPIM) for prediction of accepted latent class trajectory analysis (LCTA)-derived bronchiectasis phenotype classes in adults with non-cystic fibrosis bronchiectasis (NCFB). The Bronchiectasis Phenotype Identification Model (BPIM) is a supervised baseline phenotype classifier trained in the development cohort and applied unchanged to the validation cohort. The accepted latent class trajectory analysis (LCTA)-derived phenotype class will serve as the phenotype ground truth. Higher classification accuracy indicates better agreement between Bronchiectasis Phenotype Identification Model (BPIM)-predicted phenotype class and accepted latent class trajectory analysis (LCTA)-derived phenotype class. Unit of Measure: Percentage of participants correctly classified.

  Baseline to 12 months follow-up.

Secondary Outcomes (16)

• Accepted Latent Class Trajectory Analysis-Derived Phenotype Class

  Baseline to 12 months follow-up.

• Agreement Between Bronchiectasis Phenotype Identification Model-Predicted Class and Accepted Latent Class Trajectory Analysis-Derived Class

  Baseline to 12 months follow-up.

• Class-Specific Sensitivity of the Bronchiectasis Phenotype Identification Model

  Baseline to 12 months follow-up.

• Class-Specific Specificity of the Bronchiectasis Phenotype Identification Model

  Baseline to 12 months follow-up.

• Positive Predictive Value of the Bronchiectasis Phenotype Identification Model for Phenotype Classification

  Baseline to 12 months follow-up.

Other Outcomes (29)

• Bayesian Information Criterion of Latent Class Trajectory Analysis Solutions

  Baseline to 12 months follow-up.

• Entropy of Latent class Trajectory Analysis Solutions

  Baseline to 12 months follow-up.

• Minimum Class Size of Latent class Trajectory Analysis Solutions

  Baseline to 12 months follow-up.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB) attending outpatient clinics, inpatient wards, or respiratory follow-up services at Assiut University Hospitals during the enrollment period will be prospectively screened. Eligible participants will undergo baseline disease-signature assessment within the Bronchiectasis Phenotype Identification Model (BPIM) framework and planned longitudinal follow-up for latent class trajectory analysis (LCTA), supervised BPIM classifier development, and validation. Participants receive routine clinical care; no treatment or intervention is assigned by the protocol.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university-Faculty of Medicine

Asyut, Assiut Egypt, 71515, Egypt

RECRUITING

Related Links

• Locked BPIM Version 1.0 methodological archive including protocol, statistical analysis plan, latent class trajectory analysis variable ledger, phenotype-labeling convention, supervised classifier structure, and validation governance.

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Ahmad M Shaddad, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Aliae A. Hussien, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Maiada K. Hashem, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Alaa S. Ali, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad M Shaddad, MD

CONTACT

+201111171930; shaddad_ahmad@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 20, 2026
• Study Start: September 11, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 12 months after publication of the primary study results and for 3 years thereafter.
• Access Criteria: Access may be granted to qualified researchers submitting a methodologically sound proposal related to non-cystic fibrosis bronchiectasis (NCFB), phenotype classification, latent class trajectory analysis (LCTA), supervised prediction modeling, or respiratory translational research. Requests require approval by the principal investigator, Faculty of Medicine, Assiut University, and the relevant ethics committee when applicable. Approved requesters must sign a data use agreement covering confidentiality, restricted use, data security, no re-identification, no unauthorized redistribution, no commercial use, proper acknowledgement, and compliance with ethical and institutional regulations. Code and protected implementation materials require separate written authorization.

Locations

EG (1)