Lung Diseases, InterstitialPROGRESSNCT03858842
Non-interventional Study Describing Epidemiology, Prognosis and Patient Healthcare Costs in France, 2010-2017
An observational study of Lung Diseases, Interstitial and Lung Disease With Systemic Sclerosis, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Interstitial, Lung Disease With Systemic Sclerosis
- What is being tested?
- epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILD
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2019to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for SSc-ILD, and PF-ILD (excluding the IPF patients)
Who may be able to join
- 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
Who cannot join
- Patients treated by anti-fibrotic
- Patients diagnosed with IPF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study Describing Epidemiology, Clinical Characteristics, Prognosis and Healthcare Costs of PF-ILD and SSc-ILD Patients in France, 2010-2017
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.
- Being tested
- epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILD
- Keywords
- Progressive fibrosing interstitial lung disease, Systemic Sclerosis-Associated Interstitial Lung Disease
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| PF-ILD and SSc-ILD patients | PF-ILD and SSc-ILD patients Receives: Other: epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Between 2010 and 2017
Secondary outcomes (2)
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.
Measured: Between 2010 and 2017
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.
Measured: Between 2010 and 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study startMar 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Cottin, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858842
- Sponsor's protocol ID
- 69HCL19_0027
- Acronym
- PROGRESS
- Status last verified
- Feb 2019
- First submitted
- 27 Feb 2019
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 34552943Nasser 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 34030695Nasser 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study Describing Epidemiology, Clinical Characteristics, Prognosis and Healthcare Costs of PF-ILD and SSc-ILD Patients in France, 2010-2017
- ClinicalTrials.gov ID
- NCT03858842
- Acronym / sponsor ID
- PROGRESS / 69HCL19_0027
- Keywords
- Progressive fibrosing interstitial lung disease, Systemic Sclerosis-Associated Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF-ILD and SSc-ILD patients | – | Other: epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILDPF-ILD and SSc-ILD patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for SSc-ILD, and PF-ILD (excluding the IPF patients)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients treated by anti-fibrotic
- Patients diagnosed with IPF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILDepidemiology, characteristics, healthcare resources and associated costs of patients diagnosed with non-IPF PF-ILD and SSc-ILD | Other | PF-ILD and SSc-ILD patients |
Primary outcome
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
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
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
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
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
2 secondary outcomes
mortality for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.
Time frame: Between 2010 and 2017
Forced Vital Capacity for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.
Time frame: Between 2010 and 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Derived from this study: PubMed 34552943Cottin 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.
- Derived from this study: PubMed 34030695Nasser 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.
- Derived from this study: PubMed 32943410Nasser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Cottin, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, Interstitial and Lung Disease With Systemic Sclerosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Cottin, Pr (472 35 76 53 ext. +33, vincent.cottin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PF-ILD and SSc-ILD patients (time frame: Between 2010 and 2017). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858842, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.