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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03858842
Other study ID # 69HCL19_0027
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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