Biomarker clues for COPD, IPF, and lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This non-profit, interventional pilot study uses a prospective phase followed by retrospective tissue analysis to explore how baseline biomarker profiles relate to clinical and phenotypic characteristics in COPD, IPF, and resectable lung cancer. Participants include COPD and IPF patients who smoke or smoked, and patients with early-stage lung cancer undergoing surgery. Blood samples will be collected for inflammatory, immunological, genetic, and epigenetic testing, with follow-up at 12 months to assess prognostic value. The study plans 30 months in total, with analyses aimed at linking biomarkers to disease phenotypes and clinical outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• IRCCS Fondazione Don Carlo Gnocchi
  Milan, Milan, Italy Recruiting

Study contacts

• Principal investigator: Mario Clerici, MD — IRCCS Fondazione Don Carlo Gnocchi
• Study coordinator: Mario Clerici, MD
• Email: mario.clerici@unimi.it
• Phone: +39024030801

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.