Observational study on interstitial lung diseases from infancy to elderly
Interstitial Lung Disease: A Study From Infancy to Elderly Including Relatives
This study is collecting health information from people of all ages with interstitial lung diseases to see how these conditions affect them over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT06036719 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze clinical data from patients of all ages suffering from idiopathic interstitial pneumonias and related chronic fibrosing interstitial lung diseases. It will include both retrospective and prospective data collection over a period of approximately 10 years, with 5 years dedicated to participant enrollment and another 5 years for follow-up and data analysis. The study will involve patients with confirmed diagnoses and their relatives, regardless of genetic mutations. Participants will be informed about the study and will provide written consent before enrollment.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with idiopathic interstitial pneumonia or progressive fibrotic interstitial lung disease, as well as their relatives.
Not a fit: Patients without a confirmed diagnosis of interstitial lung disease or those with conditions unrelated to the study focus may not benefit.
Why it matters
Potential benefit: If successful, this study could enhance understanding and management of interstitial lung diseases across different age groups.
How similar studies have performed: While similar observational studies have been conducted, this particular approach focusing on a wide age range and genetic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Confirmed diagnosis of IIP established based on clinical, radiological, or functional criteria. Confirmed diagnosis of non-IPF progressive fibrotic interstitial lung disease (PF-ILD) with fibrosis ≥ 10% on CT scan, disease worsening not related to pulmonary embolism, decompensated heart failure, or lower respiratory tract infection, and disease progression despite "appropriate management" evaluated over a period of up to 24 months: * A relative decline in Forced Vital Capacity (FVC) of at least 10% from predicted value, with or without clinical deterioration, or * A combination of at least 2 of the following criteria: a relative decline in FVC between 5% and 10% from predicted value, worsening respiratory symptoms, increased extent of pulmonary fibrosis on thoracic CT scan. Confirmed diagnosis of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) (American College of Rheumatology criteria), with a total score ≥ 9 and disease extent involving ≥ 10% of the lungs (defined by reticular abnormalities, honeycombing, and ground-glass opacities) on high-resolution CT (HRCT) scan. For relatives: First degree relatives of patients carrying a mutation in TERT, TERC, RTEL1, TINF2, DKC1, PARN genes, and other telomere related genes that may be described in the future and included.
Where this trial is running
Paris, Île-de-France Region
- RaDiCo-ILD2 — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Vincent Cottin, Pr — Centre National de Référence des maladies pulmonaires rares
- Study coordinator: Vincent Cottin, Pr
- Email: vincent.cottin@chu-lyon.fr
- Phone: (33) 4 27 85 77 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.