Cystic FibrosisNOVAANCT04760548
Segmentation of Structural Abnormalities in Chronic Lung Diseases
An observational study of Cystic Fibrosis and Asthma, run by Hôpital Haut Lévêque at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Cystic Fibrosis, Asthma, COPD
- What is being tested?
- Observational study
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2008to 17 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic lung disease and a Clinical examination, pulmonary function test, and CT acquired during an annual routine follow-up
Who may be able to join
- Patients with chronic lung disease and clinical examination, pulmonary function test, and CT acquired during a routine follow-up
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Asthma, COPD, Interstitial Lung Disease
- Being tested
- Observational study
- Medical subject headings
- Cystic Fibrosis, Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| Train dataset | This group is dedicated to developing an automated algorithm Receives: Other: Observational study | |
| Test dataset | This group is dedicated to testing the semantic performance of an automated algorithm Receives: 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 Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of automated measurement
Correlations and comparisons with other biomarker of the disease severity
Measured: From date of inclusion until the date of final quantification, assessed up to 12 months
Secondary outcomes (3)
Correlation with pulmonary function test
Correlation of quantitative measurement with pulmonary function
Measured: From date of inclusion until the date of final quantification, assessed up to 12 months
Longitudinal variation over time
Comparison of quantitative measurement at two time points
Measured: From date of inclusion until the date of final quantification, assessed up to 12 months
Reproducibility
Evaluation of measurements when performed twice
Measured: From date of inclusion until the date of final quantification, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jan 2008
- Primary completion17 Feb 2024 (estimated)
- Study completion17 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Haut Lévêque
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Collaborative NOVAA study group
- Responsible party
- Sponsor-investigator, Hôpital Haut Lévêque, Hôpital Haut-Lévêque
- Investigators
- Patrick Berger, Pr, Study chair, Hopital Haut Leveque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760548
- Sponsor's protocol ID
- NOVAA
- Acronym
- NOVAA
- Status last verified
- Sep 2023
- First submitted
- 15 Feb 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Automated software measurements
Publications
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.
PubMed 34266943
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmentation of Structural Abnormalities in Chronic Lung Diseases
- ClinicalTrials.gov ID
- NCT04760548
- Acronym / sponsor ID
- NOVAA / NOVAA
- Conditions
- Cystic Fibrosis, Asthma, COPD, Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Hôpital Haut LévêqueUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Collaborative NOVAA study group
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 17 Feb 2024 (estimated)
- Study completion
- 17 Feb 2024 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Train dataset | – | Other: Observational studyThis group is dedicated to developing an automated algorithm |
| Test dataset | – | Other: Observational studyThis group is dedicated to testing the semantic performance of an automated algorithm |
| Clinical Validations | – | Other: Observational studyPatients 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 |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic lung disease and a Clinical examination, pulmonary function test, and CT acquired during an annual routine follow-up
Key inclusion criteria (1 listed)
- Patients with chronic lung disease and clinical examination, pulmonary function test, and CT acquired during a routine follow-up
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study | Other | Clinical Validations, Test dataset, Train dataset |
Primary outcome
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
3 secondary outcomes
Correlation with pulmonary function test
Time frame: 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
Reproducibility
Time frame: From date of inclusion until the date of final quantification, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 34266943Dournes 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.
- Individual participant dataSharing planned: Undecided. Automated software measurements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Berger, Pr study chair
Hopital Haut Leveque
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Asthma, run by Hôpital Haut Lévêque at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of automated measurement (time frame: From date of inclusion until the date of final quantification, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.