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

NCT07707245 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-16

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Trust Franco e Piero Gazzarrini

    collaborator UNKNOWN

  • Fondazione Don Carlo Gnocchi ETS

    lead OTHER

Principal Investigators

  • Mario Clerici, MD · IRCCS Fondazione Don Carlo Gnocchi

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-22
Primary Completion
2027-11-30
Completion
2028-10-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07707245 on ClinicalTrials.gov