Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis (EXPOSOMFPI)
2021년 10월 22일 업데이트: Assistance Publique - Hôpitaux de Paris
Idiopathic Pulmonary Fibrosis(IPF) is the most common idiopathic interstitial lung disease whose cause is unknown.
With age and gender, socio-economic factors are the most influential indicators of health.
At present there is very little data on socio-economic factors in the IPF.
The investigators hypothesize that a lower socio-economic level and / or exposure to various air pollutants may influence the IPF's natural history, including the severity of diagnosis and prognosis of the IPF.
The investigators also hypothesize that the deleterious effect of air pollutants is modulated by individual susceptibility (shorter telomeres) and that this effect is related to oxidative stress and shortening of telomeres.
연구 개요
상세 설명
Idiopathic Pulmonary Fibrosis is the most common idiopathic interstitial lung disease whose cause is unknown.
However, it remains a rare disease, there is an incidence of approximately 4400 new patients per year in France.
It is a serious disease with few therapeutic options and a median survival after diagnosis around 36 months.
It is also responsible for high morbidity, with a marked deterioration in quality of life (dyspnea, cough, fatigue and anxiodepressive disorders) and significant functional impairment (respiratory failure) With age and gender, socio-economic factors are the most influential indicators of health.
At present there is very little data on socio-economic factors in the IPF.
The investigators hypothesize that a lower socio-economic level and / or exposure to various air pollutants may influence the IPF's natural history, including the severity of diagnosis and prognosis of the IPF.
The investigators also hypothesize that the deleterious effect of air pollutants is modulated by individual susceptibility (shorter telomeres) and that this effect is related to oxidative stress and shortening of telomeres.
연구 유형
중재적
등록 (예상)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Nacira DARGHAL
- 전화번호: (+33)148957473
- 이메일: nacira.darghal@aphp.fr
연구 연락처 백업
- 이름: Lucile SESE, Dr
- 전화번호: (+33)148955923
- 이메일: lucile.sese@aphp.fr
연구 장소
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Marseille, 프랑스
- 아직 모집하지 않음
- 009 - Service Pneumologie
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수석 연구원:
- Martine REYNAUT-GAUBERT, Pr
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Avicenne
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Bobigny, Avicenne, 프랑스
- 모병
- 001 - Service Pneumologie
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수석 연구원:
- Hilario NUNES, Pr
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Bobigny, Avicenne, 프랑스
- 모병
- 002 - Service Explorations Fonctionnelles Respiratoires
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수석 연구원:
- Lucile SESE, Dr
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Bichat
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Paris, Bichat, 프랑스
- 모집하지 않고 적극적으로
- 003 - Service Pneumologie
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CHU Caen Normandie
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Caen, CHU Caen Normandie, 프랑스
- 모집하지 않고 적극적으로
- 016 - Service Pneumologie
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CHU Dijon
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Dijon, CHU Dijon, 프랑스
- 모집하지 않고 적극적으로
- 010 - Service Pneumologie
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CHU Grenoble
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Grenoble, CHU Grenoble, 프랑스
- 모집하지 않고 적극적으로
- 013 - Service Pneumologie
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CHU Lille
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Lille, CHU Lille, 프랑스
- 모집하지 않고 적극적으로
- 008 - Service Pneumologie
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CHU Montpellier
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Montpellier, CHU Montpellier, 프랑스
- 아직 모집하지 않음
- 015 - Service Pneumologie
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CHU Pontchaillou
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Rennes, CHU Pontchaillou, 프랑스
- 모병
- 007 - Service Pneumologie
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수석 연구원:
- Stéphane JOUNEAU, Pr
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CHU Strasbourg
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Strasbourg, CHU Strasbourg, 프랑스
- 모집하지 않고 적극적으로
- 011 - Service Pneumologie
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CHU Tours
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Tours, CHU Tours, 프랑스
- 모병
- 012 - Service Pneumologie
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수석 연구원:
- Sylvain MARCHAND-ADAM, Pr
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Ghef
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Meaux, Ghef, 프랑스
- 모집하지 않고 적극적으로
- 014 - Service Pneumologie
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Hegp
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Paris, Hegp, 프랑스
- 모집하지 않고 적극적으로
- 005 - Service Pneumologie
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Hospices Civils De Lyon
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Lyon, Hospices Civils De Lyon, 프랑스
- 모집하지 않고 적극적으로
- 006 - Service Pneumologie
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Tenon
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Paris, Tenon, 프랑스
- 모병
- 004 - Service de Pneumologie
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수석 연구원:
- Jacques CADRANEL, Pr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Man woman over 18 years old
- Certain or probable Idiopathic Pulmonary Fibrosis determined by a multi-disciplinary discussion ("ATS / ERS / JRS / ALAT" 2018 criteria)
- Idiopathic Pulmonary Fibrosis with a diagnosis of less than 12 months
- Signed informed consent
- Patient affiliated to a social security scheme or universal health coverage or benefiting from state medical aid
Exclusion Criteria:
- Known cause of Diffuse Interstitial Lung Disease (including connectivity, Hypersensitivity pneumonitis or pneumoconiosis authenticated)
- Patient unable to answer questionnaires
- Pregnant or lactating woman
- Persons under guardianship
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Idiopathic Pulmonary Fibrosis
Blood sample were performed during the study for all patients.
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Blood sample performed at the inclusion and during the follow-up.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Determine if the household income is associated with the severity of the IPF at inclusion
기간: Enrollment
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Patients will be classified into three groups: "lower" standard of living, "average" level and "higher" level. These groups are respectively defined by wages : less than 1000 euros, greater than or equal to 1000 euros and less than 4000 euros, and greater than or equal to 4000 euros. The severity of the IPF at baseline will be defined by the respiratory functional impact: a forced vital capacity (FVC) of less than 50% and / or a Carbon monoxide diffusion capacity of less than 30%. |
Enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Describe the general and specific external environment of patients with IPF
기간: Enrollment
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Collection of data on the general and specific external environment on patients with IPF
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Enrollment
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Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the severity of the IPF
기간: Enrollment
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Collection of data about socio-economic and environmental factors, and about severity on patients with IPF
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Enrollment
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Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the quality of life
기간: Enrollment
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Collection of data about socio-economic and environmental factors, and about quality of life on patients with IPF
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Enrollment
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Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the occurrence of an Acute Exacerbation
기간: 24 months
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Collection of data about socio-economic and environmental factors, and about occurrence of an Acute Exacerbation on patients with IPF
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24 months
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Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the progress of the IPF
기간: 24 months
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Collection of data about socio-economic and environmental factors, and about progression of IPF on patients with IPF
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24 months
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Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the mortality
기간: 24 months
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Collection of data about socio-economic and environmental factors, and about mortality of patients with IPF
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24 months
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Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the existence and type of comorbidities
기간: Enrollment
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Collection of data about socio-economic and environmental factors, and about existence and type of comorbidities on patients with IPF
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Enrollment
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Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the diagnostic and management delay
기간: Enrollment
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Collection of data about socio-economic and environmental factors, and about diagnostic and management delay on patients with IPF
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Enrollment
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Determine the impact of socio-economic factors and environmental factors on therapeutic decisions: anti-fibrotic treatments, access to transplantation
기간: 24 months
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Collection of data about socio-economic and environmental factors (occupational domestic exposures and air pollution), and about therapeutic decisions (anti-fibrotic treatments, access to transplantation) on patients with IPF
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24 months
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Determine if the deleterious effect of air pollutants on the decline of respiratory function is dependent on the size of the telomeres
기간: 24 months
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Collection of data about deleterious effect of air pollutants on the decline of respiratory function and about the length of telomers calculated with T/S ratio.
Blood samples will be performed for analysis of biomarkers and oxidative stress in IPF, measurement of telomere length, MUC5B, TOLLIP and GSTT1 polymorphisms.
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24 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Lucile SESE, Dr, Assistance Publique - Hôpitaux de Paris
- 연구 책임자: Hilario NUNES, PHD, Assistance Publique - Hôpitaux de Paris
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
- Ley B, Ryerson CJ, Vittinghoff E, Ryu JH, Tomassetti S, Lee JS, Poletti V, Buccioli M, Elicker BM, Jones KD, King TE Jr, Collard HR. A multidimensional index and staging system for idiopathic pulmonary fibrosis. Ann Intern Med. 2012 May 15;156(10):684-91. doi: 10.7326/0003-4819-156-10-201205150-00004.
- Raghu G, Rochwerg B, Zhang Y, Garcia CA, Azuma A, Behr J, Brozek JL, Collard HR, Cunningham W, Homma S, Johkoh T, Martinez FJ, Myers J, Protzko SL, Richeldi L, Rind D, Selman M, Theodore A, Wells AU, Hoogsteden H, Schunemann HJ; American Thoracic Society; European Respiratory society; Japanese Respiratory Society; Latin American Thoracic Association. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med. 2015 Jul 15;192(2):e3-19. doi: 10.1164/rccm.201506-1063ST. Erratum In: Am J Respir Crit Care Med. 2015 Sep 1;192(5):644. Dosage error in article text.
- Collard HR, Ryerson CJ, Corte TJ, Jenkins G, Kondoh Y, Lederer DJ, Lee JS, Maher TM, Wells AU, Antoniou KM, Behr J, Brown KK, Cottin V, Flaherty KR, Fukuoka J, Hansell DM, Johkoh T, Kaminski N, Kim DS, Kolb M, Lynch DA, Myers JL, Raghu G, Richeldi L, Taniguchi H, Martinez FJ. Acute Exacerbation of Idiopathic Pulmonary Fibrosis. An International Working Group Report. Am J Respir Crit Care Med. 2016 Aug 1;194(3):265-75. doi: 10.1164/rccm.201604-0801CI.
- Duchemann B, Annesi-Maesano I, Jacobe de Naurois C, Sanyal S, Brillet PY, Brauner M, Kambouchner M, Huynh S, Naccache JM, Borie R, Piquet J, Mekinian A, Virally J, Uzunhan Y, Cadranel J, Crestani B, Fain O, Lhote F, Dhote R, Saidenberg-Kermanac'h N, Rosental PA, Valeyre D, Nunes H. Prevalence and incidence of interstitial lung diseases in a multi-ethnic county of Greater Paris. Eur Respir J. 2017 Aug 3;50(2):1602419. doi: 10.1183/13993003.02419-2016. Print 2017 Aug.
- Ley B, Collard HR, King TE Jr. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):431-40. doi: 10.1164/rccm.201006-0894CI. Epub 2010 Oct 8.
- Lantz PM, House JS, Lepkowski JM, Williams DR, Mero RP, Chen J. Socioeconomic factors, health behaviors, and mortality: results from a nationally representative prospective study of US adults. JAMA. 1998 Jun 3;279(21):1703-8. doi: 10.1001/jama.279.21.1703.
- Cottin V. [French recommendations for idiopathic pulmonary fibrosis: An updated working document for clinicians]. Rev Mal Respir. 2017 Oct;34(8):789-790. doi: 10.1016/j.rmr.2017.09.005. No abstract available. French.
- King TE Jr, Pardo A, Selman M. Idiopathic pulmonary fibrosis. Lancet. 2011 Dec 3;378(9807):1949-61. doi: 10.1016/S0140-6736(11)60052-4. Epub 2011 Jun 28.
- Raghu G, Amatto VC, Behr J, Stowasser S. Comorbidities in idiopathic pulmonary fibrosis patients: a systematic literature review. Eur Respir J. 2015 Oct;46(4):1113-30. doi: 10.1183/13993003.02316-2014.
- Gershon AS, Dolmage TE, Stephenson A, Jackson B. Chronic obstructive pulmonary disease and socioeconomic status: a systematic review. COPD. 2012 Jun;9(3):216-26. doi: 10.3109/15412555.2011.648030. Epub 2012 Apr 12.
- Lederer DJ, Arcasoy SM, Barr RG, Wilt JS, Bagiella E, D'Ovidio F, Sonett JR, Kawut SM. Racial and ethnic disparities in idiopathic pulmonary fibrosis: A UNOS/OPTN database analysis. Am J Transplant. 2006 Oct;6(10):2436-42. doi: 10.1111/j.1600-6143.2006.01480.x. Epub 2006 Jul 26.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 4월 1일
기본 완료 (예상)
2022년 4월 1일
연구 완료 (예상)
2025년 4월 1일
연구 등록 날짜
최초 제출
2020년 10월 23일
QC 기준을 충족하는 최초 제출
2020년 11월 2일
처음 게시됨 (실제)
2020년 11월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 10월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 10월 22일
마지막으로 확인됨
2020년 10월 1일
추가 정보
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