Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis (EXPOSOMFPI)
22 de octubre de 2021 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Anticipado)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Nacira DARGHAL
- Número de teléfono: (+33)148957473
- Correo electrónico: nacira.darghal@aphp.fr
Copia de seguridad de contactos de estudio
- Nombre: Lucile SESE, Dr
- Número de teléfono: (+33)148955923
- Correo electrónico: lucile.sese@aphp.fr
Ubicaciones de estudio
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-
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Marseille, Francia
- Aún no reclutando
- 009 - Service Pneumologie
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Investigador principal:
- Martine REYNAUT-GAUBERT, Pr
-
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Avicenne
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Bobigny, Avicenne, Francia
- Reclutamiento
- 001 - Service Pneumologie
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Investigador principal:
- Hilario NUNES, Pr
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Bobigny, Avicenne, Francia
- Reclutamiento
- 002 - Service Explorations Fonctionnelles Respiratoires
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Investigador principal:
- Lucile SESE, Dr
-
-
Bichat
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Paris, Bichat, Francia
- Activo, no reclutando
- 003 - Service Pneumologie
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-
CHU Caen Normandie
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Caen, CHU Caen Normandie, Francia
- Activo, no reclutando
- 016 - Service Pneumologie
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CHU Dijon
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Dijon, CHU Dijon, Francia
- Activo, no reclutando
- 010 - Service Pneumologie
-
-
CHU Grenoble
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Grenoble, CHU Grenoble, Francia
- Activo, no reclutando
- 013 - Service Pneumologie
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CHU Lille
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Lille, CHU Lille, Francia
- Activo, no reclutando
- 008 - Service Pneumologie
-
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CHU Montpellier
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Montpellier, CHU Montpellier, Francia
- Aún no reclutando
- 015 - Service Pneumologie
-
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CHU Pontchaillou
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Rennes, CHU Pontchaillou, Francia
- Reclutamiento
- 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, Francia
- Activo, no reclutando
- 011 - Service Pneumologie
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CHU Tours
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Tours, CHU Tours, Francia
- Reclutamiento
- 012 - Service Pneumologie
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Investigador principal:
- Sylvain MARCHAND-ADAM, Pr
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Ghef
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Meaux, Ghef, Francia
- Activo, no reclutando
- 014 - Service Pneumologie
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Hegp
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Paris, Hegp, Francia
- Activo, no reclutando
- 005 - Service Pneumologie
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Hospices Civils De Lyon
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Lyon, Hospices Civils De Lyon, Francia
- Activo, no reclutando
- 006 - Service Pneumologie
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Tenon
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Paris, Tenon, Francia
- Reclutamiento
- 004 - Service de Pneumologie
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Investigador principal:
- Jacques CADRANEL, Pr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Determine if the household income is associated with the severity of the IPF at inclusion
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Describe the general and specific external environment of patients with IPF
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Lucile SESE, Dr, Assistance Publique - Hôpitaux de Paris
- Director de estudio: Hilario NUNES, PHD, Assistance Publique - Hôpitaux de Paris
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de abril de 2021
Finalización primaria (Anticipado)
1 de abril de 2022
Finalización del estudio (Anticipado)
1 de abril de 2025
Fechas de registro del estudio
Enviado por primera vez
23 de octubre de 2020
Primero enviado que cumplió con los criterios de control de calidad
2 de noviembre de 2020
Publicado por primera vez (Actual)
6 de noviembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
22 de octubre de 2021
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- APHP180343
- 2019-A00825-52 (Otro identificador: ANSM - IDRCB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .