Non-small Cell Lung Cancer
Conditions
Brief summary
The purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples can increase the percentage of patients with advanced non-squamous non-small cell lung cancer in whom both pathologic subtyping and mutational analysis are obtained.
Interventions
Rapid on-site evaluation consists on the cytological evaluation of samples obtained during a diagnostic procedure by a pathologist present in the diagnostic suite. In the present study, cytological samples obtained with EBUS-TBNA during bronchoscopy will be evaluated.
DEVICEEBUS-TBNA
EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy
Sponsors
Maggiore Bellaria Hospital, Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Suspected hilar or mediastinal lymph node metastasis from lung cancer
Exclusion criteria
* Pregnancy * Uncontrolled coagulopathy * Refusal to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes | 18 months | Percentage of patients for whom the mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes on EBUS-TBNA samples is obtained |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic yield of EBUS-TBNA | 18 months |
| Adequacy of EBUS-TBNA samples | 18 months |
Countries
Italy
Outcome results
None listed