NCT05751538

Brief Summary

Bronchiectasis is a chronic respiratory disease characterized by permanent bronchiectasis.The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Chest computed tomography (CT) remains the imaging standard for demonstrating cystic fibrosis (CF) airway structural disease in vivo. However, visual scoring systems as an outcome measure are time consuming, require training and lack high reproducibility. Our objective was to validate a fully automated artificial intelligence (AI)-driven scoring system of CF lung disease severity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
730

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 2, 2023

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

February 8, 2023

Last Update Submit

February 20, 2023

Conditions

Keywords

BronchiectasisMachine LearningArtificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • Correlations of the artificial intelligence-driven scores with manual scores

    Correlations and comparisons of the artificial intelligence-driven scores with manual scores by thoracic radiologists on CT scans of bronchiectasis patients.

    From date of inclusion until the date of final quantification, assessed up to 12 months

Secondary Outcomes (1)

  • Correlation of the artificial intelligence-driven scores with pulmonary function test

    From date of inclusion until the date of final quantification, assessed up to 12 months

Study Arms (3)

Train dataset

This group is dedicated to developing an automated algorithm.

Other: No intervention

Test dataset

This group is dedicated to testing the performance of an automated algorithm.

Other: No intervention

Clinical Validation

This group is dedicated to assessing the clinical validity of the measurement in an independent validation cohort.

Other: No intervention

Interventions

No intervention

Clinical ValidationTest datasetTrain dataset

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with bronchiectasis and clinical examination, pulmonary function test, and CT data

You may qualify if:

  • Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis)

You may not qualify if:

  • Patients with CT data and medical records missing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Medical School of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 2, 2023

Study Start

March 1, 2023

Primary Completion

June 30, 2023

Study Completion

December 30, 2023

Last Updated

March 2, 2023

Record last verified: 2022-11

Locations