DNA and RNA testing from bronchial lavage to guide genetic analysis in advanced NSCLC

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

Patients with advanced NSCLC often need repeat tissue sampling to identify targetable mutations and mechanisms of drug resistance, but biopsies can be difficult or risky for small or peripheral lung lesions. This single-center interventional protocol collects bronchial lavage during bronchoscopy and isolates extracellular vesicles and other nucleic acids for DNA and RNA NGS analysis. Sequencing results from lavage-derived material will be compared with prior cytological or histological NGS when available to measure concordance and practical utility. The study aims to clarify whether bronchial lavage EV-derived NGS can act as a reliable alternative or complement to tissue and plasma liquid biopsies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years;
* Indication for bronchoscopic cytological sampling for further diagnosis of suspected stage IV lung cancer on CT (computed tomography)/PET (positron emission tomography) scans, with consequent need for NGS analysis.
* Indication for bronchoscopy in patients with known lung cancer who have already undergone NGS analysis on a cytological-histological sample in the previous five years.
* Acquisition of written informed consent.

Exclusion Criteria:

* Confirmation of small cell lung cancer or other non-NSCLC pathology where there is no indication for NGS testing.

Where it's running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Bologna, Italy Recruiting

Study contacts

• Principal investigator: Gian Piero Bandelli, md — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Gian Piero Bandelli, MD
• Email: gianpiero.bandelli@aosp.bo.it
• Phone: 0039 051 214 5251

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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.