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

NCT07707245 | Recruiting

• 1 other identifier: RESPIRO
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Idiopathic Pulmonary Fibrosis (IPF); Lung Cancer

Outcome Measures

Primary Outcomes (14)

• Innate immunity

  Macrophages, monocytes, neutrophils, and dendritic cells (for all: % of total blood cells)

  Baseline

• 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)

  baseline

• 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)

  baseline

• 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)

  baseline

• Forced Expiratory Volume in 1 second

  Forced Expiratory Volume in 1 second (FEV1) (%)

  baseline and after 12 months

• VC

  Vital Capacity (VC) (%)

  baseline and after 12 months

• Total Lung Capacity

  Total Lung Capacity (TLC) (%)

  baseline and after 12 months

• Inspiratory Capacity

  Inspiratory Capacity (IC) (%)

  baseline and after 12 months

• Expiratory Reserve Volume

  Expiratory Reserve Volume (ERV) %)

  Baseline and after 12 months

• Residual Volume

  Residual Volume (RV) (%)

  Baseline and after 12 months

• Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume

  Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume (DLCO/AV) (%)

  Baseline and after 12 months

• Blood gas analysis - PaO2

  PaO2 (mmHg)

  Baseline and after 12 months

• Blood gas analysis - PaCO2

  PaCO2 (mmHg)

  baseline and after 12 months

• Test 6 minute walk

  Test 6 minute walk (metres)

  baseline and after 12 months

Study Arms (1)

Biomarker Assessment

EXPERIMENTAL

Participants with chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), or resectable lung carcinoma will undergo peripheral blood collection at baseline for inflammatory, immunological, genetic, and epigenetic biomarker analyses. Clinical and functional data will be collected at baseline, and participants will undergo a 12-month follow-up to evaluate the prognostic value of the identified biomarkers.

Procedure: Peripheral Blood Collection

Interventions

Peripheral Blood Collection PROCEDURE

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.

Biomarker Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Severe comorbid conditions limiting life expectancy or ability to complete follow-up (e.g., advanced heart failure, severe renal or hepatic disease).
• Inadequate biological sample quality or impossibility to obtain required blood samples.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi ETS: lead
• Trust Franco e Piero Gazzarrini: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Milan, Milan, 20148, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Idiopathic Pulmonary Fibrosis; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Mario Clerici, MD

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Clerici, MD

CONTACT

+39024030801; mario.clerici@unimi.it

Simone Agostini, PhD

CONTACT

+390240308375; sagostini@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 16, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)