NCT06512142

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

November 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

July 15, 2024

Last Update Submit

July 15, 2024

Conditions

Keywords

complex networkslung imagingspectral analysisgeolocation

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    September 2024 - March 2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The primary specialized Victor Babes Respiratory Hospital patients

You may qualify if:

  • 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);

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Victor Babes" University Hospital

Timișoara, Timiș County, Romania

Location

MeSH Terms

Conditions

Lung NeoplasmsEmphysema

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 22, 2024

Study Start

November 1, 2023

Primary Completion

December 30, 2024

Study Completion

March 31, 2025

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations