DNA and RNA testing from bronchial lavage to guide genetic analysis in advanced NSCLC
The Role of DNA and RNA From Extracellular Vescicles Obtained by Bronchial Lavage in NGS Analyses for Advaced Stage NSCLC Patients
The team will test whether analyzing DNA and RNA from bronchial lavage (wash) samples gives useful next-generation sequencing (NGS) results for people with advanced non-small cell lung cancer who need genetic testing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT07188480 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with suspected or known stage IV non-small cell lung cancer who have an indication for bronchoscopy and need NGS testing, and who can give informed consent, are ideal candidates.
Not a fit: Patients with confirmed small cell lung cancer or other non-NSCLC pathologies, or those who cannot undergo bronchoscopy, are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive repeat tissue biopsies and improve detection of actionable mutations to guide targeted therapy.
How similar studies have performed: Plasma cell-free DNA liquid biopsy has shown utility in detecting some tumor mutations, but using extracellular vesicle-derived DNA/RNA from bronchial lavage is a newer approach with limited prior validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bologna, Bologna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.