Interstitial Lung Disease Due to Systemic Disease (Disorder)OCEAN-ILDNCT07577115
Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases.
An observational study of Interstitial Lung Disease Due to Systemic Disease (Disorder) and Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder), run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease Due to Systemic Disease (Disorder), Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder), Exposure Occupational
- What is being tested?
- standard interview
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2026to Dec 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Sarcoidosis
- Primary diagnosis of COPD and/or Asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases: a Prospective Observational Study.
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.
Read the 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.
- 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
- Being tested
- standard interview
- 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
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Alveolitis, Extrinsic Allergic, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard interviewOther
standard interview to detect relevant exposures
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: standard interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Use of a standardized questionnaire in all the centers
To standardise exposure assessment through a structured questionnaire across participating centres
Measured: 5 years
Secondary outcomes (3)
The prevalence of environmental and/or occupational exposures in patients diagnosed with IPF, HP or other forms of ILD
To compare the frequency of any exposure among patients with idiopathic pulmonary fibrosis (IPF), hypersensitivity pneumonitis (HP), and other forms of ILD
Measured: 5 years
All-cause mortality
All-cause mortality
Measured: 5 years
Development of a progressive pulmonary fibrosis (PPF) phenotype.
To evaluate the percentage of patients developing a progressive pulmonary fibrosis (PPF) phenotype in the "exposure" and "no exposure" group.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Apr 2026
- Primary completionDec 2034 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung Disease Due to Systemic Disease (Disorder)Studies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova, Azienda Ospedaliera Universitaria Senese
- Responsible party
- Sponsor
- Investigators
- Francesco Amati, MD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577115
- Sponsor's protocol ID
- Prot. Nr. 57/26
- Acronym
- OCEAN-ILD
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28414524Morell 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.
PubMed 24429272Lee 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.
PubMed 33621598Cottin 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.
PubMed 30578335Raghu 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.
PubMed 30168753
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT07577115
- Acronym / sponsor ID
- OCEAN-ILD / Prot. Nr. 57/26
- 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
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- University of Padova, Azienda Ospedaliera Universitaria Senese
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILD Patients Undergoing Exposure Assessment | – | Other: standard interviewEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Sarcoidosis
- Primary diagnosis of COPD and/or Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard interviewstandard interview to detect relevant exposures | Other | ILD Patients Undergoing Exposure Assessment |
Primary outcome
Frequency of any exposure (environmental and/or occupational) in ILD patients.
Time frame: 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
Time frame: 5 years
To standardise exposure assessment through a structured questionnaire across participating centres
3 secondary outcomes
The prevalence of environmental and/or occupational exposures in patients diagnosed with IPF, HP or other forms of ILD
Time frame: 5 years
All-cause mortality
Time frame: 5 years
Development of a progressive pulmonary fibrosis (PPF) phenotype.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 28414524Ryerson 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.
- Background: PubMed 24429272Morell 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.
- Background: PubMed 33621598Lee 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.
- Background: PubMed 30578335Cottin 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.
- Background: PubMed 30168753Raghu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Amati, MD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease Due to Systemic Disease (Disorder) and Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder), run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of any exposure (environmental and/or occupational) in ILD patients. (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07577115, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.