Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases. (OCEAN-ILD)
Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases: a Prospective Observational Study.
연구 개요
상태
정황
개입 / 치료
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Italy
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Rozzano, Italy, 이탈리아, 20089
- Humanitas Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
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standard interview to detect relevant exposures
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of any exposure (environmental and/or occupational) in ILD patients.
기간: 5 years
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to assess the frequency of environmental and/or occupational exposures among patients with newly diagnosed ILD
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5 years
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Use of a standardized questionnaire in all the centers
기간: 5 years
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To standardise exposure assessment through a structured questionnaire across participating centres
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5 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The prevalence of environmental and/or occupational exposures in patients diagnosed with IPF, HP or other forms of ILD
기간: 5 years
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To compare the frequency of any exposure among patients with idiopathic pulmonary fibrosis (IPF), hypersensitivity pneumonitis (HP), and other forms of ILD
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5 years
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All-cause mortality
기간: 5 years
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All-cause mortality
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5 years
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Development of a progressive pulmonary fibrosis (PPF) phenotype.
기간: 5 years
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To evaluate the percentage of patients developing a progressive pulmonary fibrosis (PPF) phenotype in the "exposure" and "no exposure" group.
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5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Francesco Amati, MD, Humanitas Research Hospital IRCCS, Rozzano-Milan
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- Prot. Nr. 57/26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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