Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases.

NCT07577115 | Active Not Recruiting

• 1 other identifier: Prot. Nr. 57/26
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (2)

• Frequency of any exposure (environmental and/or occupational) in ILD patients.

  to assess the frequency of environmental and/or occupational exposures among patients with newly diagnosed ILD

  5 years

• Use of a standardized questionnaire in all the centers

  To standardise exposure assessment through a structured questionnaire across participating centres

  5 years

Secondary Outcomes (3)

• The prevalence of environmental and/or occupational exposures in patients diagnosed with IPF, HP or other forms of ILD

  5 years

• All-cause mortality

  5 years

• Development of a progressive pulmonary fibrosis (PPF) phenotype.

  5 years

Study Arms (1)

ILD Patients Undergoing Exposure Assessment

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.

Other: standard interview

Interventions

standard interview OTHER

standard interview to detect relevant exposures

ILD Patients Undergoing Exposure Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be identified during routine ILD outpatient visits and enrolled after written informed consent. Baseline data collection will occur at the time of enrollment. Diagnostic consistency will be ensured through multidisciplinary discussion (MDD). The contribution of exposure history to diagnostic refinement and additional testing will be systematically recorded. Data will be prospectively collected using a standardised CRF at baseline and every 6 months (±2 months), in line with clinical practice. A structured questionnaire assessing environmental and occupational exposures will be: * Administered at baseline * Re-administered at each follow-up visit Exposure domains will include: * Occupational exposures (dusts, fibres, chemicals) * Domestic exposures (mould, animals, biomass) * Hobbies and recreational exposures * Drug-related exposures Exposure relevance will be evaluated during MDD.

You may qualify if:

• 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

You may not qualify if:

• Sarcoidosis
• Primary diagnosis of COPD and/or Asthma

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• University of Padova: collaborator
• Azienda Ospedaliera Universitaria Senese: collaborator

Study Sites (1)

Humanitas research hospital

Rozzano, Italy, 20089, Italy

Location

Related Publications (5)

• Ryerson CJ, Corte TJ, Lee JS, Richeldi L, Walsh SLF, Myers JL, Behr J, Cottin V, Danoff SK, Flaherty KR, Lederer DJ, Lynch DA, Martinez FJ, Raghu G, Travis WD, Udwadia Z, Wells AU, Collard HR. A Standardized Diagnostic Ontology for Fibrotic Interstitial Lung Disease. An International Working Group Perspective. Am J Respir Crit Care Med. 2017 Nov 15;196(10):1249-1254. doi: 10.1164/rccm.201702-0400PP. No abstract available.

  PMID: 28414524 BACKGROUND

• Morell F, Villar A, Montero MA, Munoz X, Colby TV, Pipvath S, Cruz MJ, Raghu G. Chronic hypersensitivity pneumonitis in patients diagnosed with idiopathic pulmonary fibrosis: a prospective case-cohort study. Lancet Respir Med. 2013 Nov;1(9):685-94. doi: 10.1016/S2213-2600(13)70191-7. Epub 2013 Oct 21.

  PMID: 24429272 BACKGROUND

• Lee CT, Adegunsoye A, Chung JH, Ventura IB, Jablonski R, Montner S, Vij R, Hines SE, Strek ME. Characteristics and Prevalence of Domestic and Occupational Inhalational Exposures Across Interstitial Lung Diseases. Chest. 2021 Jul;160(1):209-218. doi: 10.1016/j.chest.2021.02.026. Epub 2021 Feb 20.

  PMID: 33621598 BACKGROUND

• Cottin V, Hirani NA, Hotchkin DL, Nambiar AM, Ogura T, Otaola M, Skowasch D, Park JS, Poonyagariyagorn HK, Wuyts W, Wells AU. Presentation, diagnosis and clinical course of the spectrum of progressive-fibrosing interstitial lung diseases. Eur Respir Rev. 2018 Dec 21;27(150):180076. doi: 10.1183/16000617.0076-2018. Print 2018 Dec 31.

  PMID: 30578335 BACKGROUND

• Raghu G, Remy-Jardin M, Myers JL, Richeldi L, Ryerson CJ, Lederer DJ, Behr J, Cottin V, Danoff SK, Morell F, Flaherty KR, Wells A, Martinez FJ, Azuma A, Bice TJ, Bouros D, Brown KK, Collard HR, Duggal A, Galvin L, Inoue Y, Jenkins RG, Johkoh T, Kazerooni EA, Kitaichi M, Knight SL, Mansour G, Nicholson AG, Pipavath SNJ, Buendia-Roldan I, Selman M, Travis WD, Walsh S, Wilson KC; American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 1;198(5):e44-e68. doi: 10.1164/rccm.201807-1255ST.

  PMID: 30168753 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Alveolitis, Extrinsic Allergic; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Francesco Amati, MD

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 11, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

IT (1)