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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04760548
Other study ID # NOVAA
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2008
Est. completion date February 17, 2024

Study information

Verified date September 2023
Source Hôpital Haut-Lévêque
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 800
Est. completion date February 17, 2024
Est. primary completion date February 17, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years to 70 Years
Eligibility Inclusion Criteria: - Patients with chronic lung disease and clinical examination, pulmonary function test, and CT acquired during a routine follow-up

Study Design


Intervention

Other:
Observational study


Locations

Country Name City State
France Hopital Haut Leveque Pessac

Sponsors (3)

Lead Sponsor Collaborator
Hôpital Haut Lévêque Collaborative NOVAA study group, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validity of automated measurement 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 Correlation with pulmonary function test Correlation of quantitative measurement with pulmonary function From date of inclusion until the date of final quantification, assessed up to 12 months
Secondary Longitudinal variation over time Comparison of quantitative measurement at two time points From date of inclusion until the date of final quantification, assessed up to 12 months
Secondary Reproducibility Evaluation of measurements when performed twice From date of inclusion until the date of final quantification, assessed up to 12 months
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