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Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases. (OCEAN-ILD)

5. maj 2026 opdateret af: Istituto Clinico Humanitas

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • Italy
      • Rozzano, Italy, Italien, 20089
        • Humanitas Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: standard interview
standard interview to detect relevant exposures

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency of any exposure (environmental and/or occupational) in ILD patients.
Tidsramme: 5 years
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
Tidsramme: 5 years
To standardise exposure assessment through a structured questionnaire across participating centres
5 years

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istituto Clinico Humanitas

Samarbejdspartnere

University of Padova
Azienda Ospedaliera Universitaria Senese

Efterforskere

  • Ledende efterforsker: Francesco Amati, MD, Humanitas Research Hospital IRCCS, Rozzano-Milan

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2026

Primær færdiggørelse (Anslået)

1. december 2034

Studieafslutning (Anslået)

1. december 2034

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Prot. Nr. 57/26

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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