Primary Objective:
To evaluate the association between inflammatory, immunological, genetic, and epigenetic biomarkers measured at enrollment and the clinical, functional, and phenotypic characteristics of patients with chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and lung cancer.
Secondary Objective:
To assess the prognostic value of the identified biomarkers by evaluating their ability to predict clinical outcomes at 12 months.
Primary Outcome Measure:
Association between baseline inflammatory, immunological, genetic, and epigenetic biomarkers and disease-specific clinical, functional, and phenotypic characteristics assessed at enrollment, including:
COPD: current or former smokers, stratified according to the predominant phenotype (emphysema or bronchiolitis); IPF: rapid progressors, slow progressors, and patients with combined pulmonary fibrosis and emphysema (CPFE); Lung cancer: current smokers, former smokers who quit less than 15 years before enrollment, former smokers who quit 15 years or more before enrollment, and never-smokers.
Secondary Outcome Measure:
Predictive performance of baseline inflammatory, immunological, genetic, and epigenetic biomarkers for 12-month clinical outcomes.
Age ≥ 18 years.
Clinical diagnosis of: Chronic Obstructive Pulmonary Disease (COPD), current or former smokers; and/or Idiopathic Pulmonary Fibrosis (IPF), current or former smokers; and/or Resectable lung adenocarcinoma (Stage I-III, according to clinical indication for surgical resection).
Ability to comply with study procedures and follow-up visits.
Inability or unwillingness to provide informed consent.
Active respiratory infection or acute exacerbation of COPD or IPF at the time of enrollment.
Previous or concomitant malignant disease (except non-melanoma skin cancer) that could interfere with study objectives.
Prior systemic immunosuppressive or anti-inflammatory therapy that may significantly alter immune profiling within a defined washout period (if applicable per protocol).
Single group
Peripheral Blood Collection
Procedure/SurgeryPeripheral venous blood collection (approximately 40 mL) for inflammatory, immunological, genetic, and epigenetic biomarker analyses, including PBMC isolation, serum collection, genomic DNA extraction, and microRNA analysis.
Innate immunity
Macrophages, monocytes, neutrophils, and dendritic cells (for all: % of total blood cells)
Genetic polymorphisms
KIR, HLA-Cw, VDR, GC1, IL-1β, IL-1Ra, IL-6, IL-10, IL-13, IL-18, TGF-β1, TNF-α (for all: presence or absence)
Adaptive immunity
CTLA-4, PD-1, PDL-1, PDL-2, Galectin-9, LAG-3, TIM-3, VISTA, TIGIT, IL-10, TGF-β, IL-13, IL-35, IL-17 IL-21, IL-1β, IL-6, IL-23, IL-22 (for all: ng/ml)
serum microRNAs
serum miR-155-5p, miR-146a-5p, miR-181a-5p, miR-223-3p, miR-431-5p, miR-149-3p, miR-335-5p and miR-206 (for all: copies/ul)
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Fondazione Don Carlo Gnocchi ETS
Lead sponsor
Trust Franco e Piero Gazzarrini
Collaborator
