Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases.

Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases: a Prospective Observational Study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07577115

Acronym

OCEAN-ILD

Enrollment

1000

Registered

2026-05-11

Start date

2026-04-01

Completion date

2034-12-01

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exposure Occupational, Exposure to Chemical Pollution, Occupational, Exposure to Environmental Pollution, Exposure to Household Air Pollution, Hypersensitivity Pneumonitis, Idiopathic Pulmonary Fibrosis (IPF), ILD, ILD Progression and Exposure to Indoor Environnemental Risk, ILD Progression and Exposure to Outdoor Polluants, Interstitial Lung Disease Due to Systemic Disease (Disorder), Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder), Occupational Exposure, Progressive Pulmonary Fibrosis

Keywords

ILD, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Occupational Exposure, Progressive Pulmonary Fibrosis, Exposure to Environmental Pollution, Exposure to Chemical Pollution, Occupational, Exposure to household air pollution, Hypersensitivity pneumonitis, chronic hypersensitivity pneumonitis, acute hypersensitivity pneumonitis, extrinsic allergic alveolitis

Brief summary

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.

Detailed description

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.

Interventions

OTHERstandard interview

standard interview to detect relevant exposures

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Frequency of any exposure (environmental and/or occupational) in ILD patients.	5 years	to assess the frequency of environmental and/or occupational exposures among patients with newly diagnosed ILD
Use of a standardized questionnaire in all the centers	5 years	To standardise exposure assessment through a structured questionnaire across participating centres

Secondary

Measure	Time frame	Description
The prevalence of environmental and/or occupational exposures in patients diagnosed with IPF, HP or other forms of ILD	5 years	To compare the frequency of any exposure among patients with idiopathic pulmonary fibrosis (IPF), hypersensitivity pneumonitis (HP), and other forms of ILD
All-cause mortality	5 years	All-cause mortality
Development of a progressive pulmonary fibrosis (PPF) phenotype.	5 years	To evaluate the percentage of patients developing a progressive pulmonary fibrosis (PPF) phenotype in the "exposure" and "no exposure" group.

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORFrancesco Amati, MD

Humanitas Research Hospital IRCCS, Rozzano-Milan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026