Status:
RECRUITING
Interstitial Lung Disease: A Study From Infancy to Elderly Including Relatives
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Interstitial Lung Diseases
Eligibility:
All Genders
Brief Summary
The concerned patients are children and adults suffering from idiopathic interstitial pneumonias, other chronic fibrosing interstitial pneumonias with a progressive phenotype, and interstitial pneumon...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 19 2031
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06036719
Start Date
January 19 2022
End Date
March 19 2031
Last Update
January 29 2025
Active Locations (1)
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1
RaDiCo-ILD2
Paris, Île-de-France Region, France, 75012