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Enrolling by invitationNCT06512142SmartLungsUpdated Jul 22, 2024

Using Artificial Intelligence for the Detection of Respiratory Diseases Associated With Pollution

An observational study in COPD Asthma, Lung Neoplasm and Emphysema, sponsored by University of Medicine and Pharmacy "Victor Babes" Timisoara. Enrolling by invitation at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by University of Medicine and Pharmacy "Victor Babes" Timisoara · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30,000
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • COPD Asthma
  • Lung Neoplasm
  • Emphysema

Keywords

  • complex networks
  • lung imaging
  • spectral analysis
  • geolocation
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 30,000 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Medicine and Pharmacy "Victor Babes" Timisoara is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The primary specialized Victor Babes Respiratory Hospital patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must be diagnosed with 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);

Exclusion criteria

Exclusion Criteria:

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: December 2023 - December 2024

  2. 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.

    Time frame: September 2024 - March 2024

07

Study locations

1 site
  • "Victor Babes" University Hospital
    Timisoara, Timis, Romania
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06512142
Lead sponsor
University of Medicine and Pharmacy "Victor Babes" Timisoara
Responsible party
Ana Adriana Trusculescu (Dr., University of Medicine and Pharmacy "Victor Babes" Timisoara) — Principal investigator
First posted
Jul 22, 2024
Start date
Nov 1, 2023
Primary completion
Dec 30, 2024 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Jul 22, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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