NCT06644144

P4O2 ILD Extension

Early Identification of Progressive Pulmonary Fibrosis, Precision Medicine for More Oxygen - ILD Extension.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to identify early biomarkers that can predict the development of progressive pulmonary fibrosis (PPF) in participants with interstitial lung diseases (ILDs). The participant population includes adults diagnosed with idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), other fibrotic ILDs, and interstitial lung abnormalities (ILA). The main questions it aims to answer are: * What biomarkers and risk factors are linked to fibrosis progression or can predict rapid worsening and sudden flare-ups in IPF and FPF patients? * What biomarkers and risk factors can predict the development of a PPF phenotype in different types of ILD? * What biomarkers and risk factors can help identify ILA patients who may develop significant ILD? * What biomarkers and risk factors can predict how well ILD patients will respond to treatment? Researchers will compare the outcomes between participants diagnosed with IPF/FPF, other fibrotic ILDs, and ILA to see if early detection biomarkers differ among these groups. Participants will: * Undergo blood sampling. * Perform lung function tests. * Have CT scans. * Perform breath analysis * Participate in exposome and microbiome analyses. * Complete questionnaires. * A subgroup of participants will be offered bronchoscopy.

Detailed description

Included participants will complete several study visits to collect clinical data and biological samples. Study visits will be performed at baseline, 3, 6, 12, 24, 36, 48 and 60 months, with a 2-month time window for follow-up visits. These time points are aligned with the standard clinical follow-up visits outlined in the ILD Care Path Protocol of Amsterdam UMC.

Conditions

• Interstitial Lung Disease
• Pulmonary Fibrosis
• Interstitial Lung Fibrosis
• IPF
• Pulmonary Fibrosis, Idiopathic
• Pulmonary Fibrosis Idiopathic Familial
• Chronic Hypersensitivity Pneumonitis
• Unclassifiable ILD
• Idiopathic NSIP
• CTD-ILD

Interventions

Type	Name	Description
OTHER	No Interventions	No intervention so not applicable.

Timeline

• Start date: 2024-11-01
• Primary completion: 2028-10-01
• Completion: 2031-10-01
• First posted: 2024-10-16
• Last updated: 2025-04-03

Locations

1 site across 1 country: Netherlands