Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis (EXPOSOMFPI)
22 ottobre 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
200
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Nacira DARGHAL
- Numero di telefono: (+33)148957473
- Email: nacira.darghal@aphp.fr
Backup dei contatti dello studio
- Nome: Lucile SESE, Dr
- Numero di telefono: (+33)148955923
- Email: lucile.sese@aphp.fr
Luoghi di studio
-
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Marseille, Francia
- Non ancora reclutamento
- 009 - Service Pneumologie
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Investigatore principale:
- Martine REYNAUT-GAUBERT, Pr
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Avicenne
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Bobigny, Avicenne, Francia
- Reclutamento
- 001 - Service Pneumologie
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Investigatore principale:
- Hilario NUNES, Pr
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Bobigny, Avicenne, Francia
- Reclutamento
- 002 - Service Explorations Fonctionnelles Respiratoires
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Investigatore principale:
- Lucile SESE, Dr
-
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Bichat
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Paris, Bichat, Francia
- Attivo, non reclutante
- 003 - Service Pneumologie
-
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CHU Caen Normandie
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Caen, CHU Caen Normandie, Francia
- Attivo, non reclutante
- 016 - Service Pneumologie
-
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CHU Dijon
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Dijon, CHU Dijon, Francia
- Attivo, non reclutante
- 010 - Service Pneumologie
-
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CHU Grenoble
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Grenoble, CHU Grenoble, Francia
- Attivo, non reclutante
- 013 - Service Pneumologie
-
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CHU Lille
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Lille, CHU Lille, Francia
- Attivo, non reclutante
- 008 - Service Pneumologie
-
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CHU Montpellier
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Montpellier, CHU Montpellier, Francia
- Non ancora reclutamento
- 015 - Service Pneumologie
-
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CHU Pontchaillou
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Rennes, CHU Pontchaillou, Francia
- Reclutamento
- 007 - Service Pneumologie
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Investigatore principale:
- Stéphane JOUNEAU, Pr
-
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CHU Strasbourg
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Strasbourg, CHU Strasbourg, Francia
- Attivo, non reclutante
- 011 - Service Pneumologie
-
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CHU Tours
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Tours, CHU Tours, Francia
- Reclutamento
- 012 - Service Pneumologie
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Investigatore principale:
- Sylvain MARCHAND-ADAM, Pr
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Ghef
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Meaux, Ghef, Francia
- Attivo, non reclutante
- 014 - Service Pneumologie
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Hegp
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Paris, Hegp, Francia
- Attivo, non reclutante
- 005 - Service Pneumologie
-
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Hospices Civils De Lyon
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Lyon, Hospices Civils De Lyon, Francia
- Attivo, non reclutante
- 006 - Service Pneumologie
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Tenon
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Paris, Tenon, Francia
- Reclutamento
- 004 - Service de Pneumologie
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Investigatore principale:
- Jacques CADRANEL, Pr
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Determine if the household income is associated with the severity of the IPF at inclusion
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Describe the general and specific external environment of patients with IPF
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Lucile SESE, Dr, Assistance Publique - Hôpitaux de Paris
- Direttore dello studio: Hilario NUNES, PHD, Assistance Publique - Hôpitaux de Paris
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 aprile 2021
Completamento primario (Anticipato)
1 aprile 2022
Completamento dello studio (Anticipato)
1 aprile 2025
Date di iscrizione allo studio
Primo inviato
23 ottobre 2020
Primo inviato che soddisfa i criteri di controllo qualità
2 novembre 2020
Primo Inserito (Effettivo)
6 novembre 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 ottobre 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 ottobre 2021
Ultimo verificato
1 ottobre 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- APHP180343
- 2019-A00825-52 (Altro identificatore: ANSM - IDRCB)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .