Identification of Diagnostic and Prognostic Biomarkers in the Pathological Continuum of Bronco Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis and Pulmonary Neoplasia

Condition(s) studied

Investigational drug(s) / intervention(s)

Peripheral Blood Collection: Peripheral 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Innate immunity — Baseline
  Macrophages, monocytes, neutrophils, and dendritic cells (for all: % of total blood cells)
• Genetic polymorphisms — baseline
  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 — baseline
  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 — baseline
  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)
• Forced Expiratory Volume in 1 second — baseline and after 12 months
  Forced Expiratory Volume in 1 second (FEV1) (%)
• VC — baseline and after 12 months
  Vital Capacity (VC) (%)
• Total Lung Capacity — baseline and after 12 months
  Total Lung Capacity (TLC) (%)
• Inspiratory Capacity — baseline and after 12 months
  Inspiratory Capacity (IC) (%)
• Expiratory Reserve Volume — Baseline and after 12 months
  Expiratory Reserve Volume (ERV) %)
• Residual Volume — Baseline and after 12 months
  Residual Volume (RV) (%)
• Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume — Baseline and after 12 months
  Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume (DLCO/AV) (%)
• Blood gas analysis - PaO2 — Baseline and after 12 months
  PaO2 (mmHg)
• Blood gas analysis - PaCO2 — baseline and after 12 months
  PaCO2 (mmHg)
• Test 6 minute walk — baseline and after 12 months
  Test 6 minute walk (metres)

Trial sites (1)

More Fondazione Don Carlo Gnocchi ETS trials in Italy

Other trials for the same condition