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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-TBNA + Rapid on-site evaluation | Experimental | Patients in this arm will undergo rapid-on site evaluation of samples obtained with EBUS-TBNA |
|
| EBUS-TBNA | Active Comparator | Patients in this arm will undergo EBUS-TBNA without rapid on-site evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid on-site evaluation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes | 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 | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield of EBUS-TBNA | 18 months | |
| Adequacy of EBUS-TBNA samples | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rocco Trisolini, MD | Maggiore Hospital, Bologna, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maggiore Hospital | Bologna | Emilia-Romagna | 40133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26158441 | Derived | Trisolini R, Cancellieri A, Tinelli C, de Biase D, Valentini I, Casadei G, Paioli D, Ferrari F, Gordini G, Patelli M, Tallini G. Randomized Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration With and Without Rapid On-site Evaluation for Lung Cancer Genotyping. Chest. 2015 Dec;148(6):1430-1437. doi: 10.1378/chest.15-0583. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000090044 | Rapid On-site Evaluation |
| ID | Term |
|---|---|
| D000067716 | Point-of-Care Testing |
| D019095 | Point-of-Care Systems |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| EBUS-TBNA | Device | EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |