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

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ClinicalTrials.gov Identifier: NCT03858842
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Lung Diseases, Interstitial Lung Disease With Systemic Sclerosis Other: epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILD

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non-interventional Study Describing Epidemiology, Clinical Characteristics, Prognosis and Healthcare Costs of PF-ILD and SSc-ILD Patients in France, 2010-2017
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
PF-ILD and SSc-ILD patients
PF-ILD and SSc-ILD patients
Other: epidemiology, 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




Primary Outcome Measures :
  1. 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.:

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

  2. 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.:

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

  3. 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.:

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

  4. 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.:

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

  5. 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.:

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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized for SSc-ILD, and PF-ILD (excluding the IPF patients)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858842


Contacts
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Contact: Vincent Cottin, Pr 472 35 76 53 ext +33 vincent.cottin@chu-lyon.fr

Locations
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France
Hôpital Cardiologique Louis Pradel Not yet recruiting
Bron, France
Contact: Vincent Cottin, Pr         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Vincent Cottin, Pr Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03858842     History of Changes
Other Study ID Numbers: 69HCL19_0027
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Progressive fibrosing interstitial lung disease
Systemic Sclerosis-Associated Interstitial Lung Disease

Additional relevant MeSH terms:
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Sclerosis
Lung Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases