NCT04760548

Brief 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.

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
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 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

Study Start

First participant enrolled

January 1, 2008

Completed
13.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2024

Completed
Last Updated

January 5, 2024

Status Verified

September 1, 2023

Enrollment Period

16.1 years

First QC Date

February 15, 2021

Last Update Submit

December 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Correlation with pulmonary function test

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

  • Longitudinal variation over time

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

  • Reproducibility

    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: 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

Interventions

Clinical ValidationsTest datasetTrain dataset

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Haut Leveque

Pessac, France

Location

Related Publications (1)

  • Dournes G, Hall CS, Willmering MM, Brody AS, Macey J, Bui S, Denis de Senneville B, Berger P, Laurent F, Benlala I, Woods JC. Artificial intelligence in computed tomography for quantifying lung changes in the era of CFTR modulators. Eur Respir J. 2022 Mar 3;59(3):2100844. doi: 10.1183/13993003.00844-2021. Print 2022 Mar.

MeSH Terms

Conditions

Cystic FibrosisAsthmaPulmonary Disease, Chronic ObstructiveLung Diseases, Interstitial

Interventions

Observation

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Patrick Berger, Pr

    Hopital Haut Leveque

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 18, 2021

Study Start

January 1, 2008

Primary Completion

February 17, 2024

Study Completion

February 17, 2024

Last Updated

January 5, 2024

Record last verified: 2023-09

Locations