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

Lung Diseases, Interstitial Clinical Trial

— PROGRESS  

Official title:

Non-interventional Study Describing Epidemiology, Clinical Characteristics, Prognosis and Healthcare Costs of PF-ILD and SSc-ILD Patients in France, 2010-2017

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03858842
• Other study ID #: 69HCL19_0027
• Status: Not yet recruiting
• Start date: March 2019
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Hospices Civils de Lyon
• Contact: Vincent Cottin, Pr
• Phone: 472 35 76 53
• Email: vincent.cottin[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Disease With Systemic Sclerosis
• Lung Diseases
• Lung Diseases, Interstitial
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Cardiologique Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Between 2010 and 2017
Primary	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	Between 2010 and 2017
Primary	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	Between 2010 and 2017
Primary	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	Between 2010 and 2017
Primary	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	Between 2010 and 2017
Secondary	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.	Between 2010 and 2017
Secondary	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.	Between 2010 and 2017