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Status unknownNCT03858842PROGRESSUpdated Mar 8, 2019

Non-interventional Study Describing Epidemiology, Prognosis and Patient Healthcare Costs in France, 2010-2017

An observational study in Lung Diseases, Interstitial and Lung Disease With Systemic Sclerosis, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-08.

Sponsored by Hospices Civils de Lyon · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Lung Diseases, Interstitial
  • Lung Disease With Systemic Sclerosis

Keywords

  • Progressive fibrosing interstitial lung disease
  • Systemic Sclerosis-Associated Interstitial Lung Disease
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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 100 is below the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients hospitalized for SSc-ILD, and PF-ILD (excluding the IPF patients)

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

Exclusion Criteria:

  • Patients treated by anti-fibrotic
  • Patients diagnosed with IPF
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • PF-ILD and SSc-ILD patients

    PF-ILD and SSc-ILD patients

    Other: epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILD

Interventions

  • Otherepidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILD

    epidemiology, characteristics, healthcare resources and associated costs of patients diagnosed with non-IPF PF-ILD and SSc-ILD

06

What researchers measure

Primary outcomes

  1. Incidence of PF-ILD and SSc-ILD patients

    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.: * the epidemiology (incidence and prevalence), * the characteristics of patients, * the healthcare resource use and associated costs

    Time frame: Between 2010 and 2017

  2. Prevalence of PF-ILD and SSc-ILD patients

    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.: * the epidemiology (incidence and prevalence), * the characteristics of patients, * the healthcare resource use and associated costs

    Time frame: Between 2010 and 2017

  3. characteristics of PF-ILD and SSc-ILD patients

    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.: * the epidemiology (incidence and prevalence), * the characteristics of patients, * the healthcare resource use and associated costs

    Time frame: Between 2010 and 2017

  4. healthcare resource use of PF-ILD and SSc-ILD patients

    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.: * the epidemiology (incidence and prevalence), * the characteristics of patients, * the healthcare resource use and associated costs

    Time frame: Between 2010 and 2017

  5. associated costs of PF-ILD and SSc-ILD patients

    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.: * the epidemiology (incidence and prevalence), * the characteristics of patients, * the healthcare resource use and associated costs

    Time frame: Between 2010 and 2017

Secondary outcomes

  1. mortality for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.

    correlation between mortality and FVC for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.

    Time frame: Between 2010 and 2017

  2. Forced Vital Capacity for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.

    correlation between mortality and FVC for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.

    Time frame: Between 2010 and 2017

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Study locations

1 site
  • Hôpital Cardiologique Louis Pradel
    Bron, France
    • Vincent Cottin, Pr · Contact
08

References and documents

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. PubMed 34552943 ↗
  • 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. PubMed 34030695 ↗
  • 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. PubMed 32943410 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03858842
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Mar 1, 2019
Start date
Mar 2019 (estimated)
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Mar 8, 2019

Study contacts

Vincent Cottin, Pr
Contact
vincent.cottin@chu-lyon.fr
472 35 76 53 ext. +33
Vincent Cottin, Pr
principal investigator · Hospices Civils de Lyon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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