Pulmonary Fibrosis Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Fondazione Don Carlo Gnocchi
RECRUITING
Milan
Contact Information
Primary
Mario Clerici, MD
mario.clerici@unimi.it
+39024030801
Backup
Simone Agostini, PhD
sagostini@dongnocchi.it
+390240308375
Time Frame
Start Date: 2026-04-22
Estimated Completion Date: 2028-10-30
Participants
Target number of participants: 120
Treatments
Experimental: Biomarker Assessment
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.
Sponsors
Collaborators: Trust Franco e Piero Gazzarrini
Leads: Fondazione Don Carlo Gnocchi ETS

This content was sourced from clinicaltrials.gov