Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis (EXPOSOMFPI)
22. oktober 2021 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Nacira DARGHAL
- Telefonnummer: (+33)148957473
- E-mail: nacira.darghal@aphp.fr
Undersøgelse Kontakt Backup
- Navn: Lucile SESE, Dr
- Telefonnummer: (+33)148955923
- E-mail: lucile.sese@aphp.fr
Studiesteder
-
-
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Marseille, Frankrig
- Ikke rekrutterer endnu
- 009 - Service Pneumologie
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Ledende efterforsker:
- Martine REYNAUT-GAUBERT, Pr
-
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Avicenne
-
Bobigny, Avicenne, Frankrig
- Rekruttering
- 001 - Service Pneumologie
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Ledende efterforsker:
- Hilario NUNES, Pr
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Bobigny, Avicenne, Frankrig
- Rekruttering
- 002 - Service Explorations Fonctionnelles Respiratoires
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Ledende efterforsker:
- Lucile SESE, Dr
-
-
Bichat
-
Paris, Bichat, Frankrig
- Aktiv, ikke rekrutterende
- 003 - Service Pneumologie
-
-
CHU Caen Normandie
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Caen, CHU Caen Normandie, Frankrig
- Aktiv, ikke rekrutterende
- 016 - Service Pneumologie
-
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CHU Dijon
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Dijon, CHU Dijon, Frankrig
- Aktiv, ikke rekrutterende
- 010 - Service Pneumologie
-
-
CHU Grenoble
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Grenoble, CHU Grenoble, Frankrig
- Aktiv, ikke rekrutterende
- 013 - Service Pneumologie
-
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CHU Lille
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Lille, CHU Lille, Frankrig
- Aktiv, ikke rekrutterende
- 008 - Service Pneumologie
-
-
CHU Montpellier
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Montpellier, CHU Montpellier, Frankrig
- Ikke rekrutterer endnu
- 015 - Service Pneumologie
-
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CHU Pontchaillou
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Rennes, CHU Pontchaillou, Frankrig
- Rekruttering
- 007 - Service Pneumologie
-
Ledende efterforsker:
- Stéphane JOUNEAU, Pr
-
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CHU Strasbourg
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Strasbourg, CHU Strasbourg, Frankrig
- Aktiv, ikke rekrutterende
- 011 - Service Pneumologie
-
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CHU Tours
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Tours, CHU Tours, Frankrig
- Rekruttering
- 012 - Service Pneumologie
-
Ledende efterforsker:
- Sylvain MARCHAND-ADAM, Pr
-
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Ghef
-
Meaux, Ghef, Frankrig
- Aktiv, ikke rekrutterende
- 014 - Service Pneumologie
-
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Hegp
-
Paris, Hegp, Frankrig
- Aktiv, ikke rekrutterende
- 005 - Service Pneumologie
-
-
Hospices Civils De Lyon
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Lyon, Hospices Civils De Lyon, Frankrig
- Aktiv, ikke rekrutterende
- 006 - Service Pneumologie
-
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Tenon
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Paris, Tenon, Frankrig
- Rekruttering
- 004 - Service de Pneumologie
-
Ledende efterforsker:
- Jacques CADRANEL, Pr
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Idiopathic Pulmonary Fibrosis
Blood sample were performed during the study for all patients.
|
Blood sample performed at the inclusion and during the follow-up.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Determine if the household income is associated with the severity of the IPF at inclusion
Tidsramme: Enrollment
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Describe the general and specific external environment of patients with IPF
Tidsramme: Enrollment
|
Collection of data on the general and specific external environment on patients with IPF
|
Enrollment
|
|
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the severity of the IPF
Tidsramme: Enrollment
|
Collection of data about socio-economic and environmental factors, and about severity on patients with IPF
|
Enrollment
|
|
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the quality of life
Tidsramme: Enrollment
|
Collection of data about socio-economic and environmental factors, and about quality of life on patients with IPF
|
Enrollment
|
|
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the occurrence of an Acute Exacerbation
Tidsramme: 24 months
|
Collection of data about socio-economic and environmental factors, and about occurrence of an Acute Exacerbation on patients with IPF
|
24 months
|
|
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the progress of the IPF
Tidsramme: 24 months
|
Collection of data about socio-economic and environmental factors, and about progression of IPF on patients with IPF
|
24 months
|
|
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the mortality
Tidsramme: 24 months
|
Collection of data about socio-economic and environmental factors, and about mortality of patients with IPF
|
24 months
|
|
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the existence and type of comorbidities
Tidsramme: Enrollment
|
Collection of data about socio-economic and environmental factors, and about existence and type of comorbidities on patients with IPF
|
Enrollment
|
|
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the diagnostic and management delay
Tidsramme: Enrollment
|
Collection of data about socio-economic and environmental factors, and about diagnostic and management delay on patients with IPF
|
Enrollment
|
|
Determine the impact of socio-economic factors and environmental factors on therapeutic decisions: anti-fibrotic treatments, access to transplantation
Tidsramme: 24 months
|
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
|
24 months
|
|
Determine if the deleterious effect of air pollutants on the decline of respiratory function is dependent on the size of the telomeres
Tidsramme: 24 months
|
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.
|
24 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lucile SESE, Dr, Assistance Publique - Hôpitaux de Paris
- Studieleder: Hilario NUNES, PHD, Assistance Publique - Hôpitaux de Paris
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
- 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.
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 2021
Primær færdiggørelse (Forventet)
1. april 2022
Studieafslutning (Forventet)
1. april 2025
Datoer for studieregistrering
Først indsendt
23. oktober 2020
Først indsendt, der opfyldte QC-kriterier
2. november 2020
Først opslået (Faktiske)
6. november 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. oktober 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. oktober 2021
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- APHP180343
- 2019-A00825-52 (Anden identifikator: ANSM - IDRCB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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