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Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis

NCT ID: NCT04619199

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2025-04-01

Brief Summary

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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

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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.

Conditions

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Idiopathic Pulmonary Fibrosis Pulmonary Disease Pulmonary Medicine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Longitudinal prospective cohort study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Idiopathic Pulmonary Fibrosis

Blood sample were performed during the study for all patients.

Group Type EXPERIMENTAL

Blood sample

Intervention Type DIAGNOSTIC_TEST

Blood sample performed at the inclusion and during the follow-up.

Interventions

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Blood sample

Blood sample performed at the inclusion and during the follow-up.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucile SESE, Dr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Hilario NUNES, PHD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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001 - Service Pneumologie

Bobigny, Avicenne, France

Site Status RECRUITING

002 - Service Explorations Fonctionnelles Respiratoires

Bobigny, Avicenne, France

Site Status RECRUITING

003 - Service Pneumologie

Paris, Bichat, France

Site Status ACTIVE_NOT_RECRUITING

016 - Service Pneumologie

Caen, CHU Caen Normandie, France

Site Status ACTIVE_NOT_RECRUITING

010 - Service Pneumologie

Dijon, CHU Dijon, France

Site Status ACTIVE_NOT_RECRUITING

013 - Service Pneumologie

Grenoble, CHU Grenoble, France

Site Status ACTIVE_NOT_RECRUITING

008 - Service Pneumologie

Lille, CHU Lille, France

Site Status ACTIVE_NOT_RECRUITING

015 - Service Pneumologie

Montpellier, CHU Montpellier, France

Site Status NOT_YET_RECRUITING

007 - Service Pneumologie

Rennes, CHU Pontchaillou, France

Site Status RECRUITING

011 - Service Pneumologie

Strasbourg, CHU Strasbourg, France

Site Status ACTIVE_NOT_RECRUITING

012 - Service Pneumologie

Tours, CHU Tours, France

Site Status RECRUITING

014 - Service Pneumologie

Meaux, GHEF, France

Site Status ACTIVE_NOT_RECRUITING

005 - Service Pneumologie

Paris, HEGP, France

Site Status ACTIVE_NOT_RECRUITING

006 - Service Pneumologie

Lyon, Hospices Civils de Lyon, France

Site Status ACTIVE_NOT_RECRUITING

004 - Service de Pneumologie

Paris, Tenon, France

Site Status RECRUITING

009 - Service Pneumologie

Marseille, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Nacira DARGHAL

Role: CONTACT

[email protected]
(+33)148957473

Lucile SESE, Dr

Role: CONTACT

[email protected]
(+33)148955923

References

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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.

Reference Type BACKGROUND
PMID: 28775045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21471066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26177183 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29102032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21719092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20935110 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27299520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22586007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26424523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9624022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22497534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16869805 (View on PubMed)

Other Identifiers

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2019-A00825-52

Identifier Type: OTHER

Identifier Source: secondary_id

APHP180343

Identifier Type: -

Identifier Source: org_study_id