ILD cohort

P4O2 is building a prospective, non-interventional observational cohort of ILD patients across three arms, at both clinical and pathophysiological levels:

• Arm 1: IPF/FPF group (n=150).
• Arm 2: Fibrotic ILD group (fILD) at risk for the development of PPF, including cHP, iNSIP, CTD-ILD and uILD (n=150)
• Arm 3: ILA group (n=150).

P4O2 parameters:

In all three arms of this cohort, next to biomarker analysis, we will collect the samples and measurements as listed below. These measurements align with the other P4O2 cohorts, including the PARASOL and COPD cohorts which will allow for data analysis over the different cohorts. 

• Exhaled breath analysis including eNose measurement, PExA analysis, and volatile organic compounds (VOCs) analysis by gas chromatography-mass spectrometry (GC-MS). VOCs have the potential to mirror various metabolic processes locally within the respiratory system and systemically through the blood circulation. VOCs have been utilized as diagnostic, prognostic, and treatment response biomarkers for various respiratory illnesses, including ILD.
• Peripheral Blood Mononuclear Cell (PBMC) populations in blood.
• HRCT-scan analyses; Novel imaging analyses techniques may be used to stratify the severity of lung involvement and predict outcomes (in kind contribution by imaging partners of P4O2).
• External exposome analyses; This includes lifestyle, dietary information (food diaries), and the evaluation of the physical/chemical environment. Previous studies have shown that built environment characteristics, such as ambient air pollution, may be a risk factors for ILD (optional: additional funding will be requested).
• Metabolome analyses in urine (optional: additional funding will be requested).
• Microbiome analyses in stool and nasal swabs. The gut and respiratory microbiome are important for effective immune response regulation. Analyzing the microbiome in stool and nasal swabs can provide insights into the microbial composition and its potential relationship to ILD. (optional: additional funding will be requested).
• Genomics, epigenomics and transcriptome analysis in blood (optional: additional funding will be requested).

 

Timeline P4O2. Time in months. Made with BioRender. Definition of abbreviations: BAL= bronchoalveolar lavage, HRCT= high-resolution computed tomography, ILA= interstitial lung abnormality, PBMC= peripheral blood mononuclear cells, VOC= volatile organic compound. 

 

Extra measurements and sample collections will be performed at clinical relevant events. Clinical relevant events are defined as follows:

1. Additional diagnostic measurements e.g., bronchoscopic immunological BAL and/or bronchoscopic lung cryobiopsy/surgical lung biopsy.
2. Rapid progression of disease outside the fixed time points.
3. Treatment switch.
4. Lung transplantation.
5. Acute exacerbation.
6. Pulmonary hypertension development.