Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis
- Conditions
- Pulmonary MedicineIdiopathic Pulmonary FibrosisPulmonary Disease
- Interventions
- Diagnostic Test: Blood sample
- Registration Number
- NCT04619199
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Idiopathic Pulmonary Fibrosis Blood sample Blood sample were performed during the study for all patients.
- Primary Outcome Measures
Name Time Method Determine if the household income is associated with the severity of the IPF at inclusion 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%.
- Secondary Outcome Measures
Name Time Method Describe the general and specific external environment of patients with IPF Enrollment Collection of data on the general and specific external environment on patients with IPF
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the quality of life Enrollment Collection of data about socio-economic and environmental factors, and about quality of life on patients with IPF
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the progress of the IPF 24 months Collection of data about socio-economic and environmental factors, and about progression of IPF on patients with IPF
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the severity of the IPF Enrollment Collection of data about socio-economic and environmental factors, and about severity on patients with IPF
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the occurrence of an Acute Exacerbation 24 months Collection of data about socio-economic and environmental factors, and about occurrence of an Acute Exacerbation on patients with IPF
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the mortality 24 months Collection of data about socio-economic and environmental factors, and about mortality of patients with IPF
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the existence and type of comorbidities Enrollment Collection of data about socio-economic and environmental factors, and about existence and type of comorbidities on patients with IPF
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the diagnostic and management delay Enrollment Collection of data about socio-economic and environmental factors, and about diagnostic and management delay on patients with IPF
Determine the impact of socio-economic factors and environmental factors on therapeutic decisions: anti-fibrotic treatments, access to transplantation 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
Determine if the deleterious effect of air pollutants on the decline of respiratory function is dependent on the size of the telomeres 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.
Trial Locations
- Locations (16)
002 - Service Explorations Fonctionnelles Respiratoires
🇫🇷Bobigny, Avicenne, France
016 - Service Pneumologie
🇫🇷Caen, CHU Caen Normandie, France
010 - Service Pneumologie
🇫🇷Dijon, CHU Dijon, France
013 - Service Pneumologie
🇫🇷Grenoble, CHU Grenoble, France
008 - Service Pneumologie
🇫🇷Lille, CHU Lille, France
014 - Service Pneumologie
🇫🇷Meaux, Ghef, France
007 - Service Pneumologie
🇫🇷Rennes, CHU Pontchaillou, France
011 - Service Pneumologie
🇫🇷Strasbourg, CHU Strasbourg, France
004 - Service de Pneumologie
🇫🇷Paris, Tenon, France
005 - Service Pneumologie
🇫🇷Paris, Hegp, France
009 - Service Pneumologie
🇫🇷Marseille, France
012 - Service Pneumologie
🇫🇷Tours, CHU Tours, France
006 - Service Pneumologie
🇫🇷Lyon, Hospices Civils De Lyon, France
001 - Service Pneumologie
🇫🇷Bobigny, Avicenne, France
003 - Service Pneumologie
🇫🇷Paris, Bichat, France
015 - Service Pneumologie
🇫🇷Montpellier, CHU Montpellier, France