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Building a tool to sort adults with non-cystic fibrosis bronchiectasis into types

Tests a model that sorts adults with bronchiectasis into types from baseline information.

Key facts

Who runs it
Assiut University
Where
Asyut, EgyptSee the site
Trial code
Registry title
Bronchiectasis Phenotype Identification Model
Status
Recruiting
People taking part
750 people, planned
Started
11 Sept 2025
Expected to end
1 Dec 2026
Type of study
Observational, 2 groups
Record updated
20 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with bronchiectasis that is not caused by cystic fibrosis. They are followed over time and receive their usual care.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Non-cystic fibrosis bronchiectasis, diagnosed by a clinical check and a high-resolution CT scan (HRCT).

Main reasons for not taking part

  • Bronchiectasis caused by cystic fibrosis
  • Active lung tuberculosis at enrollment
  • Active nontuberculous mycobacterial lung disease needing specific treatment
  • Active cancer or a terminal illness outside the lungs that would prevent follow-up
  • Cannot complete the planned follow-up, or refuses to take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Recent major thoracic surgery or acute thoracic trauma interfering with baseline respiratory assessment
  • 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
  • Inability to complete required baseline disease-signature assessment according to the Bronchiectasis Phenotype Identification Model (BPIM) protocol
  • Cystic fibrosis-related bronchiectasis
  • Inability or unwillingness to complete planned longitudinal follow-up
  • Refusal to participate

Where in Egypt

  • Assiut University- Faculty of MedicineAsyut, EgyptContact: Ahmad M Shaddad, MDTaking people

About the trial

What the trial wants to find out

The Bronchiectasis Phenotype Identification Model (BPIM) is a prospective observational development-validation study within the Assiut University bronchiectasis translational research platform.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • 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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
BPIM: Bronchiectasis Phenotype Identification Model for Supervised Baseline Translation of Latent Class Trajectory Analysis-Derived Phenotypes in Non-Cystic Fibrosis Bronchiectasis
Plain-language title
Building a tool to sort adults with non-cystic fibrosis bronchiectasis into typesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
20 May 2026