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Recruiting NCT06644144

P4O2 ILD Extension

— Observational Interstitial Lung Disease Pulmonary Fibrosis Interstitial Lung Fibrosis IPF

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Interventions.
Who it may be relevant to
Registry conditions: Interstitial Lung Disease, Pulmonary Fibrosis, Interstitial Lung Fibrosis, IPF. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other No Interventions
    No intervention so not applicable.

Primary outcome measures

  • 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))]
  • Pulmonary function tests (PFTs)- Spirometry volumes [Time frame: It will be measured at baseline, at 3, 6, and 12 months, and every other year till end of follow-up (60months))]
  • Pulmonary function tests (PFTs)- DLCO measurement [Time frame: It will be measured at baseline, at 3, 6, and 12 months, and every other year till end of follow-up (60months))]
  • Pulmonary function tests (PFTs)- Lungvolume measurement [Time frame: It will be measured at baseline, at 3, 6, and 12 months, and every other year till end of follow-up (60months))]
  • Biomarkers related to pulmonary fibrosis will be measured in plasma and serum [Time frame: It will be measured at baseline, at 3, 6, and 12 months, and every other year till end of follow-up (60months))]
  • Peripheral blood mononuclear cell (PBMC) populations in blood [Time frame: It will be measured Will be measured at baseline, at 3, 6 months, 12 months, and every other year till end of follow-up (60months)]
  • Exhaled breath analysis including volatile organic compounds [Time frame: It will be measured at baseline, at 3, 6, and 12 months, and every other year till end of follow-up (60months))]
Secondary outcome measures (12)
  • Disease-relevant questionnaires: Exposure Questionnaire [Time frame: Questionnaires will be filled in at baseline, at 6, and 12 months, and every other year till end of follow-up (60months))]
  • Disease-relevant questionnaires: KBILD questionnaire. [Time frame: Questionnaires will be filled in at baseline, at 6, and 12 months, and every other year till end of follow-up (60months))]
  • Disease-relevant questionnaires: Modified Medical Research Council Dyspnea score [Time frame: Questionnaires will be filled in at baseline, at 6, and 12 months, and every other year till end of follow-up (60months))]
  • Disease-relevant questionnaires: Visual analog scale (VAS) [Time frame: Questionnaires will be filled in at baseline, at 6, and 12 months, and every other year till end of follow-up (60months))]
  • Disease-relevant questionnaires: Fatigue Severity Scale (FSS) [Time frame: Questionnaires will be filled in at baseline, at 6, and 12 months, and every other year till end of follow-up (60months))]
  • Genomics analysis in blood. [Time frame: Genomics are done once at baseline.]
  • Epigenomics analysis in blood. [Time frame: Epigonomics are done at baseline and 1 year after inclusion.]
  • Transcriptome analysis in blood. [Time frame: Transcriptome is performed at baseline, 6 months and 1 year after inclusion.]
  • Proteome analysis in bronchoalveolar lavage fluid [Time frame: In Group 3, thirty participants will undergo bronchoalveolar lavage at baseline. Additional procedures may be performed during the follow-up period if clinically indicated and will be added to samples. .]
  • Microbiome analyses in stool and nasal swabs. [Time frame: Once in first year]
  • Concentration of Biomarkers in Exhaled Particles (Collected via Impaction) [Time frame: From moment of inclusion every year untill end of follow-up at 60 months.]
  • Identification of Compounds in Exhaled Particles via Mass Spectrometry (MS) [Time frame: From moment of inclusion every year untill end of follow-up at 60 months.]

Eligibility criteria

Inclusion criteria

  • Diagnosis of (1) idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), (2) other fibrotic ILDs (fILD), including fibrotic hypersensitivity pneumonitis (fHP), idiopathic non-specific interstitial pneumonia (iNSIP), connective tissue disease (CTD)-ILD, and unclassifiable ILD (uILD); or (3) interstitial lung abnormalities (ILA).
  • Meeting all the following criteria during the screening period:
  • FVC ≥45% predicted.
  • FEV1/FVC ≥0.7.
  • DLco corrected for Hb ≥40% predicted.
  • Able to provide written informed consent as approved by the independent ethics committee.
  • Able to undergo a CT scan and perform PFT.
  • Age \> 18 years and \< 80 years.
  • Understanding of the Dutch or English language.

Exclusion criteria

  • Combined pulmonary fibrosis and emphysema (CPFE) diagnosis
  • Chronic obstructive lung disease (COPD) with an FEV1/FVC \<70%.
  • Uncontrolled severe asthma.
  • Active malignancy, except for squamous cell carcinoma of the skin, low-risk breast cancer, and low-risk prostate cancer.
  • Pregnancy or lactating.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Amsterdam UMC, locatie VUmc — Amsterdam

Identifiers

NCT: NCT06644144 · 2023.0591 · NL84006.018.23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗