The Role of DNA and RNA in NGS Analyses for Advaced Stage NSCLC Patients

NCT07188480 | Recruiting

• 2 other identifiers: Geno_broncho_typingRC24000851-2790626
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with advanced non-small cell lung cancer (NSCLC) usually undergo biopsies to obtain cytological material on which to perform Next Generation Sequencing (NGS) analysis, with the aim of identifying driver gene mutations that may be targeted by specific therapies. With the development of drugs with specific therapeutic targets, the clinical need for re-biopsy or even repeated biopsies is increasing; these biopsies are necessary to identify the mechanisms of drug resistance in the target lesions. Very often, lung cancer presents with small lesions and/or lesions located in areas that are difficult to reach with traditional biopsy techniques. An alternative way to obtain genetic material is to isolate extracellular vesicles (EVs). These are secreted by almost all cell types, transport bioactive molecules, including nucleic acids (RNA and DNA), enclosed in a double lipid layer, and act as essential mediators in cell-cell communication. EVs are an ideal biomarker for cancer, as the content of EVs originating from tumor cells reflects the molecular and genetic composition of the parent cells. Long-stranded, concentrated EV-DNA is easy to amplify, making it a suitable candidate for NGS analysis. EVs are widely distributed in various body fluids, making them easier to sample using less invasive methods than tumor cells. Recent studies have shown that EVs successfully isolated from bronchoalveolar lavage (BAL) fluid of lung cancer patients contain abundant amounts of dsDNA. In a study of patients with anatomopathologically confirmed NSCLC, the sensitivity and specificity of EGFR genotyping based on BAL EVs were high, and this test showed an even better mutation detection rate than tissue/cytology-based typing. Considering the high positive predictive value of EV genotyping in bronchoalveolar lavage, this study aims to evaluate its feasibility in NGS analyses. The primary objective of the study is to determine the technical feasibility of NGS analysis on EV-DNA/RNA derived from bronchoalveolar lavage in patients with advanced NSCLC. The secondary objective is to determine the sensitivity and specificity of NGS analysis of EV-DNA/RNA derived from bronchoalveolar lavage compared to NGS analysis conducted on bronchoscopic cytological samples in patients with advanced NSCLC.

Conditions

Non Small Cell Lung Cancer NSCLC

Outcome Measures

Primary Outcomes (1)

• Adequacy ratio

  Proportion of cases in which bronchoalveolar lavage allows sufficient and adequate material to be obtained for NGS analysis of EV-DNA/RNA, compared to the total number of patients undergoing bronchoalveolar lavage.

  Up to one year after the bronchoalveolar lavage

Secondary Outcomes (1)

• Sensitivity and specificity of NGS analysis

  Up to one month after the NGS analysis has been performed (up to one year after the bronchoalveolar lavage)

Study Arms (1)

patients with suspected advanced lung cancer

EXPERIMENTAL

Patients with suspected advanced lung cancer undergo cytological and histological sampling via bronchoscopy, transthoracic or percutaneous procedures to confirm the diagnosis and, where deemed appropriate based on the characteristics of the cancer itself, to enable NGS analysis to be performed.

Diagnostic Test: bronchial lavage for NGS analysis

Interventions

bronchial lavage for NGS analysis DIAGNOSTIC_TEST

NGS analysis conducted on bronchoscopic cytological samples in patients with NSCLC

patients with suspected advanced lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Study Officials

• Gian Piero Bandelli, md

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gian Piero Bandelli, MD

CONTACT

0039 051 214 5251; gianpiero.bandelli@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 23, 2025
• Study Start: January 17, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

IT (1)