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NCT Number: NCT05140889

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

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Amelia Licari, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Prediction of asthma severity in children

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amelia Licari, MD

CONTACT

[email protected]

+39(0)382502629

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • Istituto per la Ricerca e l'Innovazione Biomedica
  • Università Ca' Foscari Venezia

Registry information

Acronym: BREATHE

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2021
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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