Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis (EXPOSOMFPI)
22 de outubro de 2021 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Antecipado)
200
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Nacira DARGHAL
- Número de telefone: (+33)148957473
- E-mail: nacira.darghal@aphp.fr
Estude backup de contato
- Nome: Lucile SESE, Dr
- Número de telefone: (+33)148955923
- E-mail: lucile.sese@aphp.fr
Locais de estudo
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Marseille, França
- Ainda não está recrutando
- 009 - Service Pneumologie
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Investigador principal:
- Martine REYNAUT-GAUBERT, Pr
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Avicenne
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Bobigny, Avicenne, França
- Recrutamento
- 001 - Service Pneumologie
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Investigador principal:
- Hilario NUNES, Pr
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Bobigny, Avicenne, França
- Recrutamento
- 002 - Service Explorations Fonctionnelles Respiratoires
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Investigador principal:
- Lucile SESE, Dr
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Bichat
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Paris, Bichat, França
- Ativo, não recrutando
- 003 - Service Pneumologie
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CHU Caen Normandie
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Caen, CHU Caen Normandie, França
- Ativo, não recrutando
- 016 - Service Pneumologie
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CHU Dijon
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Dijon, CHU Dijon, França
- Ativo, não recrutando
- 010 - Service Pneumologie
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CHU Grenoble
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Grenoble, CHU Grenoble, França
- Ativo, não recrutando
- 013 - Service Pneumologie
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CHU Lille
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Lille, CHU Lille, França
- Ativo, não recrutando
- 008 - Service Pneumologie
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CHU Montpellier
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Montpellier, CHU Montpellier, França
- Ainda não está recrutando
- 015 - Service Pneumologie
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CHU Pontchaillou
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Rennes, CHU Pontchaillou, França
- Recrutamento
- 007 - Service Pneumologie
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Investigador principal:
- Stéphane JOUNEAU, Pr
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CHU Strasbourg
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Strasbourg, CHU Strasbourg, França
- Ativo, não recrutando
- 011 - Service Pneumologie
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CHU Tours
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Tours, CHU Tours, França
- Recrutamento
- 012 - Service Pneumologie
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Investigador principal:
- Sylvain MARCHAND-ADAM, Pr
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Ghef
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Meaux, Ghef, França
- Ativo, não recrutando
- 014 - Service Pneumologie
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Hegp
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Paris, Hegp, França
- Ativo, não recrutando
- 005 - Service Pneumologie
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Hospices Civils De Lyon
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Lyon, Hospices Civils De Lyon, França
- Ativo, não recrutando
- 006 - Service Pneumologie
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Tenon
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Paris, Tenon, França
- Recrutamento
- 004 - Service de Pneumologie
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Investigador principal:
- Jacques CADRANEL, Pr
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Determine if the household income is associated with the severity of the IPF at inclusion
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Describe the general and specific external environment of patients with IPF
Prazo: Enrollment
|
Collection of data on the general and specific external environment on patients with IPF
|
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
Prazo: Enrollment
|
Collection of data about socio-economic and environmental factors, and about severity on patients with IPF
|
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
Prazo: 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
Prazo: 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
Prazo: 24 months
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Collection of data about socio-economic and environmental factors, and about progression of IPF on patients with IPF
|
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
Prazo: 24 months
|
Collection of data about socio-economic and environmental factors, and about mortality of patients with IPF
|
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
Prazo: Enrollment
|
Collection of data about socio-economic and environmental factors, and about existence and type of comorbidities on patients with IPF
|
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
Prazo: Enrollment
|
Collection of data about socio-economic and environmental factors, and about diagnostic and management delay on patients with IPF
|
Enrollment
|
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Determine the impact of socio-economic factors and environmental factors on therapeutic decisions: anti-fibrotic treatments, access to transplantation
Prazo: 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
|
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
Prazo: 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
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Lucile SESE, Dr, Assistance Publique - Hôpitaux de Paris
- Diretor de estudo: Hilario NUNES, PHD, Assistance Publique - Hôpitaux de Paris
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de abril de 2021
Conclusão Primária (Antecipado)
1 de abril de 2022
Conclusão do estudo (Antecipado)
1 de abril de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
23 de outubro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de novembro de 2020
Primeira postagem (Real)
6 de novembro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de outubro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de outubro de 2021
Última verificação
1 de outubro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- APHP180343
- 2019-A00825-52 (Outro identificador: ANSM - IDRCB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .