Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases: a Prospective Observational Study.
| Registry | NCT07577115, acronym OCEAN-ILD |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 1000 (Estimated) |
| Sponsor | Istituto Clinico Humanitas (Other); collaborators: University of Padova, Azienda Ospedaliera Universitaria Senese |
| Conditions | Interstitial Lung Disease Due to Systemic Disease (Disorder), Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder), Exposure Occupational, Occupational Exposure, Exposure to Household Air Pollution, Exposure to Chemical Pollution, Occupational, Exposure to Environmental Pollution, Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis, Hypersensitivity Pneumonitis, ILD Progression and Exposure to Indoor Environnemental Risk, ILD Progression and Exposure to Outdoor Polluants, ILD |
| Interventions | standard interview (Other) |
| Dates | start 2026-04-01, primary completion 2034-12-01 (estimated), completion 2034-12-01 (estimated), first posted 2026-05-11, last updated 2026-05-11 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Interstitial Lung Disease Due to Systemic Disease (Disorder) All trials for Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder) All trials of standard interview
The OCEAN-ILD study is designed to prospectively evaluate the prevalence and clinical relevance of environmental and occupational exposures in a large Italian cohort of patients affected by any ILD, using a standardised exposure questionnaire applied across multiple centres.
Interstitial lung diseases (ILDs) represent a diverse group of parenchymal lung disorders associated with significant morbidity and mortality, with few FDA-approved treatment options available. While certain subtypes-such as hypersensitivity pneumonitis and pneumoconiosis-are clearly linked to environmental exposures, the role of such exposures in other ILD forms remains less well defined. Recent evidence has showed that most patients across all types of ILD had potentially relevant inhalational exposures. Exposures were associated with worse transplant-free survival. Thus, identification and avoidance of exposures represent actionable targets in ILD management.
Different questionnaires have been proposed to evaluate occupational and environmental exposure in such patients. However, to date, there aren't standardized and validated questionnaires addressing exposures in patients with ILD. Interstitial lung diseases (ILDs) represent a diverse group of parenchymal lung disorders associated with significant morbidity and mortality, with few FDA-approved treatment options available. While certain subtypes-such as hypersensitivity pneumonitis and pneumoconiosis-are clearly linked to environmental exposures, the role of such exposures in other ILD forms remains less well defined. Recent evidence has showed that most patients across all types of ILD had potentially relevant inhalational exposures. Exposures were associated with worse transplant-free survival. Thus, identification and avoidance of exposures represent actionable targets in ILD management.
Different questionnaires have been proposed to evaluate occupational and environmental exposure in such patients. However, to date, there aren't standardized and validated questionnaires addressing exposures in patients with ILD. Moreover, frequency of exposure across different types of ILDs are not well defined in Italy.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ILD Patients Undergoing Exposure Assessment | Other: standard interview | Eligible participants will be adults (≥18 years) with new diagnosis of ILD according to classified according to American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age ≥ 18 years old * Any gender * Any race * Ability to give informed consent according to ICH/EU GCP, and national/local regulations. * New diagnosis of ILD according to classified according to American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias Exclusion Criteria: * Sarcoidosis * Primary diagnosis of COPD and/or Asthma
| Facility | City | Country | Status |
|---|---|---|---|
| Humanitas research hospital | Rozzano, Italy | Italy |