Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases. (OCEAN-ILD)
Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases: a Prospective Observational Study.
調査の概要
状態
条件
介入・治療
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
Italy
-
Rozzano、Italy、イタリア、20089
- Humanitas Research Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
standard interview to detect relevant exposures
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency of any exposure (environmental and/or occupational) in ILD patients.
時間枠：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
時間枠：5 years
|
To standardise exposure assessment through a structured questionnaire across participating centres
|
5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The prevalence of environmental and/or occupational exposures in patients diagnosed with IPF, HP or other forms of ILD
時間枠：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
時間枠：5 years
|
All-cause mortality
|
5 years
|
|
Development of a progressive pulmonary fibrosis (PPF) phenotype.
時間枠：5 years
|
To evaluate the percentage of patients developing a progressive pulmonary fibrosis (PPF) phenotype in the "exposure" and "no exposure" group.
|
5 years
|
協力者と研究者
捜査官
- 主任研究者：Francesco Amati, MD、Humanitas Research Hospital IRCCS, Rozzano-Milan
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- Prot. Nr. 57/26
個々の参加者データ (IPD) の計画
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