Segmentation of Structural Abnormalities in Chronic Lung Diseases (NOVAA)

December 31, 2023 updated by: Hôpital Haut Lévêque
Lung structural abnormalities are complex, time-consuming, and may lack reproducibility to evaluate visually on CT scans. The study's aim is to perform automated recognition of structural abnormalities in CT scans of patients with chronic lung diseases by using dedicated software.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Three chronic lung diseases will constitute the target of the study, by using retrospective data from each lung disease:

  • Cystic fibrosis
  • Asthma and COPD
  • Interstitial lung diseases

Dedicated algorithms will be developped for each disease condition.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France
        • Hopital Haut Leveque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic lung disease and a Clinical examination, pulmonary function test, and CT acquired during an annual routine follow-up

Description

Inclusion Criteria:

  • Patients with chronic lung disease and clinical examination, pulmonary function test, and CT acquired during a routine follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Train dataset
This group is dedicated to developing an automated algorithm
Other: Observational study
Test dataset
This group is dedicated to testing the semantic performance of an automated algorithm
Other: Observational study
Clinical Validations
Patients groups are dedicated to assessing the clinical validity of the measurement in independent validation cohorts, with or without longitudinal evaluations such as monitoring of a treatment effect
Other: Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of automated measurement
Time Frame: From date of inclusion until the date of final quantification, assessed up to 12 months
Correlations and comparisons with other biomarker of the disease severity
From date of inclusion until the date of final quantification, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation with pulmonary function test
Time Frame: From date of inclusion until the date of final quantification, assessed up to 12 months
Correlation of quantitative measurement with pulmonary function
From date of inclusion until the date of final quantification, assessed up to 12 months
Longitudinal variation over time
Time Frame: From date of inclusion until the date of final quantification, assessed up to 12 months
Comparison of quantitative measurement at two time points
From date of inclusion until the date of final quantification, assessed up to 12 months
Reproducibility
Time Frame: From date of inclusion until the date of final quantification, assessed up to 12 months
Evaluation of measurements when performed twice
From date of inclusion until the date of final quantification, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Haut Lévêque

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Collaborative NOVAA study group

Investigators

  • Study Chair: Patrick Berger, Pr, Hopital Haut Leveque

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Estimated)

February 17, 2024

Study Completion (Estimated)

February 17, 2024

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 31, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOVAA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Automated software measurements

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

3
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