COPD AsthmaSmartLungsNCT06512142
Using Artificial Intelligence for the Detection of Respiratory Diseases Associated With Pollution
An observational study of COPD Asthma and Lung Neoplasm, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.
Trial summary
Generating a picture at the city level, through geospatial and temporal grouping a lung diseases associated or exacerbated by pollution (COPD, AB and neoplasm pulmonary or pleural) and correlating this data with pollution data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Asthma, Lung Neoplasm, Emphysema
- How many people
- 30,000 participants
- Where
- 1 siteRomania
- Study dates
- 1 Nov 2023to 31 Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The primary specialized Victor Babes Respiratory Hospital patients
Who may be able to join
- Patients must be diagnosed with COPD and/or asthma and/or pulmonary neoplasm and/or secondary pulmonary, pleural or mediastinal determinations, suspected or confirmed, according to ICD-10.
- Patients will be included regardless of the type of hospitalization, continuous or day.
- The existence of freely expressed consent, carried out according to Ethics standards professional (from the observation sheet).
- For stage 2
- The use of HRCT images, in DICOM format, with a maximum cup thickness of 1.5 mm and with an average of 250 cups; no image acquisition errors;
- Imaging monitoring at a time interval;.
- Respiratory function evaluation data available: spirometry +/- the factor of gaseous diffusion (DLco);
Who cannot join
- For both stages:
- Patients who do not have a stable real domicile (eg social cases) or are not from the Timis county
- For stage 2
- Patients who do not have HRCT images available or cannot be followed.
- Patients who have insufficient quality HRCT images.
- Patients who have a history of lung surgery.
- Patients who have a history of allergies to contrast agents used in imaging HRCT.
Trial locations and contacts
1 site in 1 country.
About this study
Generating a picture at the city level, through geospatial and temporal grouping a lung diseases associated or exacerbated by pollution (COPD, AB and neoplasm pulmonary or pleural) and correlating this data with pollution data.
Development of an accurate and prognostic HRCT imaging diagnostic tool, computer assisted in the mentioned pathology, by generating an algorithm capable of to detect early the follow-up tomographic imaging lesions, as well as to evaluate objective their speed of evolution.
Validation of the proposed algorithm by comparison with medical diagnosis.
- Conditions
- COPD Asthma, Lung Neoplasm, Emphysema
- Keywords
- complex networks, lung imaging, spectral analysis, geolocation
- Medical subject headings
- Lung Neoplasms, Emphysema
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between lung diseases and pollution
Establishing the relationship between the incidence and exacerbation of lung diseases (COPD, acute bronchitis, and pulmonary or pleural neoplasms) and pollution levels through geospatial and temporal analysis at the city /county level
Measured: December 2023 - December 2024
Development of a diagnostic algorithm
Creating an accurate, computer-assisted HRCT imaging diagnostic tool designed to detect early tomographic lesions and evaluate the progression speed of these lesions in patients with the mentioned pathologies.
Measured: September 2024 - March 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Nov 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD AsthmaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Adriana Trusculescu, University of Medicine and Pharmacy "Victor Babes" Timisoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512142
- Sponsor's protocol ID
- PostdocTrusculescu/11.2023
- Acronym
- SmartLungs
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Artificial Intelligence for the Detection of Respiratory Diseases Associated With Pollution
- ClinicalTrials.gov ID
- NCT06512142
- Acronym / sponsor ID
- SmartLungs / PostdocTrusculescu/11.2023
- Conditions
- COPD Asthma, Lung Neoplasm, Emphysema
- Keywords
- complex networks, lung imaging, spectral analysis, geolocation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" TimisoaraUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 22 Jul 2024 (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.
Generating a picture at the city level, through geospatial and temporal grouping a lung diseases associated or exacerbated by pollution (COPD, AB and neoplasm pulmonary or pleural) and correlating this data with pollution data.
Development of an accurate and prognostic HRCT imaging diagnostic tool, computer assisted in the mentioned pathology, by generating an algorithm capable of to detect early the follow-up tomographic imaging lesions, as well as to evaluate objective their speed of evolution.
Validation of the proposed algorithm by comparison with medical diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The primary specialized Victor Babes Respiratory Hospital patients
Key inclusion criteria (7 listed)
- Patients must be diagnosed with COPD and/or asthma and/or pulmonary neoplasm and/or secondary pulmonary, pleural or mediastinal determinations, suspected or confirmed, according to ICD-10.
- Patients will be included regardless of the type of hospitalization, continuous or day.
- The existence of freely expressed consent, carried out according to Ethics standards professional (from the observation sheet).
- For stage 2
- The use of HRCT images, in DICOM format, with a maximum cup thickness of 1.5 mm and with an average of 250 cups; no image acquisition errors;
Key exclusion criteria (7 listed)
- Patients who do not have a stable real domicile (eg social cases) or are not from the Timis county
- For stage 2
- Patients who do not have HRCT images available or cannot be followed.
- Patients who have insufficient quality HRCT images.
- Patients who have a history of lung surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between lung diseases and pollution
Time frame: December 2023 - December 2024
Establishing the relationship between the incidence and exacerbation of lung diseases (COPD, acute bronchitis, and pulmonary or pleural neoplasms) and pollution levels through geospatial and temporal analysis at the city /county level
Development of a diagnostic algorithm
Time frame: September 2024 - March 2024
Creating an accurate, computer-assisted HRCT imaging diagnostic tool designed to detect early tomographic lesions and evaluate the progression speed of these lesions in patients with the mentioned pathologies.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COPD Asthma and Lung Neoplasm, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.
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 7 inclusion and 7 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 22 Jul 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 Romania. 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?
Correlation between lung diseases and pollution (time frame: December 2023 - December 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2024.