- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03858842
Non-interventional Study Describing Epidemiology, Prognosis and Patient Healthcare Costs in France, 2010-2017 (PROGRESS)
Non-interventional Study Describing Epidemiology, Clinical Characteristics, Prognosis and Healthcare Costs of PF-ILD and SSc-ILD Patients in France, 2010-2017
Interstitial lung diseases (ILDs) are a heterogeneous group of disorders, which encompass a wide range of conditions. In some patients with fibrosing ILDs, a progressive phenotype similar to that observed in idiopathic pulmonary fibrosis (IPF) may develop during the course of the disease (PF-ILD), including patients with systemic sclerosis (SSc)-related ILD.
The aim of the study is to estimate the incidence and prevalence and to describe the characteristics of patients diagnosed with non-IPF PF-ILD and SSc-ILD, to describe the natural course of disease, and to explore the correlation between mortality and Forced Vital Capacity (FVC) of the patients with non-IPF PF-ILD.
This study will be based on two data sources: the French national medico administrative database (SNDS) and the ILD cohort from the National French center for rare pulmonary diseases in Lyon, France.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Vincent Cottin, Pr
- Phone Number: +33 472 35 76 53
- Email: vincent.cottin@chu-lyon.fr
Study Locations
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-
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Bron, France
- Hôpital Cardiologique Louis Pradel
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Contact:
- Vincent Cottin, Pr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients hospitalized for PF-ILD and SSc-ILD in France between 01/01/2010 and 31/12/2017
- Men or women aged ≥ 18 years old at diagnosis
Exclusion Criteria:
- Patients treated by anti-fibrotic
- Patients diagnosed with IPF
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PF-ILD and SSc-ILD patients
|
epidemiology, characteristics, healthcare resources and associated costs of patients diagnosed with non-IPF PF-ILD and SSc-ILD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of PF-ILD and SSc-ILD patients
Time Frame: Between 2010 and 2017
|
The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.:
|
Between 2010 and 2017
|
Prevalence of PF-ILD and SSc-ILD patients
Time Frame: Between 2010 and 2017
|
The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.:
|
Between 2010 and 2017
|
characteristics of PF-ILD and SSc-ILD patients
Time Frame: Between 2010 and 2017
|
The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.:
|
Between 2010 and 2017
|
healthcare resource use of PF-ILD and SSc-ILD patients
Time Frame: Between 2010 and 2017
|
The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.:
|
Between 2010 and 2017
|
associated costs of PF-ILD and SSc-ILD patients
Time Frame: Between 2010 and 2017
|
The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.:
|
Between 2010 and 2017
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.
Time Frame: Between 2010 and 2017
|
correlation between mortality and FVC for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.
|
Between 2010 and 2017
|
Forced Vital Capacity for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.
Time Frame: Between 2010 and 2017
|
correlation between mortality and FVC for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.
|
Between 2010 and 2017
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent COTTIN, Pr, Hospices Civils de Lyon
Publications and helpful links
General Publications
- Cottin V, Larrieu S, Boussel L, Si-Mohamed S, Bazin F, Marque S, Massol J, Thivolet-Bejui F, Chalabreysse L, Maucort-Boulch D, Jouneau S, Hachulla E, Chollet J, Nasser M. Epidemiology, Mortality and Healthcare Resource Utilization Associated With Systemic Sclerosis-Associated Interstitial Lung Disease in France. Front Med (Lausanne). 2021 Aug 30;8:699532. doi: 10.3389/fmed.2021.699532. eCollection 2021.
- Nasser M, Larrieu S, Boussel L, Si-Mohamed S, Bazin F, Marque S, Massol J, Thivolet-Bejui F, Chalabreysse L, Maucort-Boulch D, Hachulla E, Jouneau S, Le Lay K, Cottin V. Estimates of epidemiology, mortality and disease burden associated with progressive fibrosing interstitial lung disease in France (the PROGRESS study). Respir Res. 2021 May 24;22(1):162. doi: 10.1186/s12931-021-01749-1.
- Nasser M, Larrieu S, Si-Mohamed S, Ahmad K, Boussel L, Brevet M, Chalabreysse L, Fabre C, Marque S, Revel D, Thivolet-Bejui F, Traclet J, Zeghmar S, Maucort-Boulch D, Cottin V. Progressive fibrosing interstitial lung disease: a clinical cohort (the PROGRESS study). Eur Respir J. 2021 Feb 11;57(2):2002718. doi: 10.1183/13993003.02718-2020. Print 2021 Feb.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL19_0027
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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