Clinical trial NCT03858842: Non-interventional Study Describing Epidemiology, Prognosis and Patient Healthcare Costs in France, 2010-2017
Official title: Non-interventional Study Describing Epidemiology, Clinical Characteristics, Prognosis and Healthcare Costs of PF-ILD and SSc-ILD Patients in France, 2010-2017
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Diseases, Interstitial
Lung Disease With Systemic Sclerosis
Keywords: Progressive fibrosing interstitial lung disease
Systemic Sclerosis-Associated Interstitial Lung Disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for SSc-ILD, and PF-ILD (excluding the IPF patients)

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of PF-ILD and SSc-ILD patients
timeFrame: Between 2010 and 2017
measure: Prevalence of PF-ILD and SSc-ILD patients
timeFrame: Between 2010 and 2017
measure: characteristics of PF-ILD and SSc-ILD patients
timeFrame: Between 2010 and 2017
measure: healthcare resource use of PF-ILD and SSc-ILD patients
timeFrame: Between 2010 and 2017
measure: associated costs of PF-ILD and SSc-ILD patients
timeFrame: Between 2010 and 2017
Secondary outcomes:
measure: mortality for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.
timeFrame: Between 2010 and 2017
measure: Forced Vital Capacity for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.
timeFrame: Between 2010 and 2017
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Cardiologique Louis Pradel
Study officials:
affiliation: Hospices Civils de Lyon
name: Vincent Cottin, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.