NCT03858842

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 8, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

February 27, 2019

Last Update Submit

March 6, 2019

Conditions

Lung Diseases, InterstitialLung Disease With Systemic Sclerosis

Keywords

Progressive fibrosing interstitial lung diseaseSystemic Sclerosis-Associated Interstitial Lung Disease

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

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

    Between 2010 and 2017

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

    Between 2010 and 2017

Study Arms (1)

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

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

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

PF-ILD and SSc-ILD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cardiologique Louis Pradel

Bron, France

Location

Related Publications (3)

  • 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.

    PMID: 34552943DERIVED

  • 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.

    PMID: 34030695DERIVED

  • 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.

    PMID: 32943410DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Health Care Costs

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Costs and Cost AnalysisEconomicsHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Vincent Cottin, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Cottin, Pr

CONTACT

472 35 76 53vincent.cottin@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 1, 2019

Study Start

March 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 8, 2019

Record last verified: 2019-02

Locations

FR(1)