BREATHE: Integrating Deep Learning CT-scan Model, Biological and Clinical Variables to Predict Severity of Asthma in Children

Sponsor
IRCCS Policlinico S. Matteo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05140889
Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica (Other), Università Ca' Foscari Venezia (Other)
25
1
41.3
0.6

Study Details

Study Description

Brief Summary

Artificial intelligence (AI) offers substantial opportunities for healthcare, supporting better diagnosis, treatment, prevention and personalized care. Analysis of health images is one of the most promising fields for applying AI in healthcare, contributing to better prediction, diagnosis and treatment of diseases.

Deep learning (DL) is currently one of the most powerful machine learning techniques. DL algorithms are able to learn from raw (or with little pre-processing) input data and build by themselves sophisticated abstract feature representations (useful patterns) that enable very accurate task decision making. Recently, DL has shown promising results in assisting lung disease analysis using computed tomography (CT) images.

Current severe asthma guidelines recommend high-resolution and multidetector CT as a tool for disease evaluation. CT scans contain prognostic information, as the presence of bronchial wall thickening, air trapping, bronchial luminal narrowing, and bronchiectasis are associated with longer disease duration and disease severity in adults. Only a small number of studies have reported chest CT findings in children with severe asthma, and their relationship to clinical and pathobiological parameters yielded inconsistent results. Thus, to which extent CT scans add prognostic information beyond what can be inferred from clinical and biological data is still unresolved in children.

The project is expected to build an DL-severity score to prognoses severe evolution for children with asthma, using a DL model to capture CT scan prognosis information.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aims of this project are:
    • to build a large database of clinical, biological and radiological data collected from pediatric patients with severe asthma;

    • to design and train a forecaster model based on DL techniques to predict asthma severity in children;

    • to estimate transition probabilities between asthma severity levels using a multi-state Markov model taking into account qualitative and quantitative information obtained from CT imaging.

    Our evaluation of DL-severity and existing clinical scores in childhood asthma is expected to reveal that emerging methodologies assisted by DL techniques can provide accurate severity predictions, when compared with existing clinical scores. Such an accurate prediction model would allow pediatricians to identify features that are the most indicative of severity and progression of asthma and would be employed to formulate intervention strategies and early medical attention for children.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    25 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Integrating Deep Learning CT-scan Model, Biological and Clinical Variables to Predict Severity of Asthma in Children
    Actual Study Start Date :
    Jan 20, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Jun 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    Children with severe asthma

    Group 2

    Children who undergo chest CT scan for other reasons than asthma

    Outcome Measures

    Primary Outcome Measures

    1. Prediction of asthma severity in children [3 years]

      To build a severity score to prognoses evolution for children with asthma, using a deep-learning model to capture CT scan prognosis information and integrate with clinical and laboratory data obtained from medical records.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age 6-17 years

    • confirmed diagnosis of severe asthma according to ERS/ATS guidelines

    Exclusion Criteria:
    • other diseases that may mimic asthma according to ERS/ATS guidelines (i.e., cystic fibrosis, primary ciliary dyskinesia, tracheobronchomalacia, etc)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Policlinico San Matteo Pavia Italy 27100

    Sponsors and Collaborators

    • IRCCS Policlinico S. Matteo
    • Istituto per la Ricerca e l'Innovazione Biomedica
    • Università Ca' Foscari Venezia

    Investigators

    • Principal Investigator: Amelia Licari, MD, IRCCS Policlinico San Matteo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amelia Licari, MD, IRCCS Policlinico S. Matteo
    ClinicalTrials.gov Identifier:
    NCT05140889
    Other Study ID Numbers:
    • 08073521
    First Posted:
    Dec 2, 2021
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amelia Licari, MD, IRCCS Policlinico S. Matteo
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 3, 2022