P4O2 ILD Extension

Sponsor
Amsterdam UMC, location VUmc
Study ID
NCT06644144
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • No Interventions — OTHER
    No intervention so not applicable.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
May 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2031

Study Design

Enrollment
450 participants (estimated)

Arms

  • Arm: Idiopathic Pulmonary Fibrosis/Familial Pulmonary Fibrosis
  • Arm: fibrotic ILD
    Patients with a diagnosis of: chronic Hypersensitivity Pneumonitis (cHP), unclassifiable ILD (uILD), idiopathic NSIP or CTD-ILD.
  • Arm: Interstitial Lung Abnormalities

Primary Outcome Measure

Inflammatory and fibrosis extent assessed by HRCT [ Time Frame: A baseline HRCT scan will be performed during screening. Following inclusion in the study, HRCT scans will be repeated annually, starting one year after the initial scan, and continuing each year until the end of follow-up (at 5 years)) ]

Central Contacts

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