Study on DNA and RNA for Advanced Lung Cancer Treatment
The Role of DNA and RNA in NGS Analyses for Advaced Stage NSCLC Patients
Recruiting
N/AInterventional Study
Non Small Cell Lung Cancer NSCLC
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
10 (estimated)
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Other
Who this trial is looking for
This trial is looking for patients with advanced non-small cell lung cancer (NSCLC) who need a specific type of lung cancer test called NGS analysis. Participants will provide samples to help researchers understand more about their cancer and how to treat it.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have suspected stage IV lung cancer confirmed by CT or PET scans.
I need bronchoscopy for further diagnosis.
I have received NGS analysis on a previous sample in the last five years.
I understand the information provided and give my written consent.
You may not be able to join if
I have small cell lung cancer.
I have any other type of lung cancer that does not need NGS testing.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 inc…
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.
Trial Locations
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Eligibility 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 wi…
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.
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