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The study is aimed at verifying if a pulmonologist can reliably assess the tumor burden for the extractive molecular analysis in ROSE samples obtained with endoscopic sampling procedures from intrathoracic lymphadenopathy and pulmonary nodules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid on-site evaluation (ROSE) | Evaluation, made by a pulmonologist, a pathologist and a molecular pathologist, of the tumor burden in ROSE slides produced from endoscopic procedures aimed at sampling intrathoracic lymphadenopathy and pulmonary nodules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid on-site evaluation | Diagnostic Test | Specimens obtained with endoscopic sampling procedures are stained with a rapid method (i.e., Diff Qui) and submitted to on-site cytologic review |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy with which a pulmonologist can assess the tumor burden on ROSE slides | The outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the molecular pathologist judgment, the latter being the gold standard | The time frame is the duration of each bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Interobserver agreement between pulmonologist, pathologist and molecular pathologist in then assessment of the tumor burden on ROSE slides | The outcome 2 will be measured by verifying the agreement between the 3 professionals, using the judgment of the molecular pathologist as gold standard | The time frame is the duration of each bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with indication to bronchoscopy or endosonography for suspected lung cancer based on imaging (CT and/or PET)
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| Name | Affiliation | Role |
|---|---|---|
| Rocco Trisolini, MD | Policlinico S. Orsola, Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maggiore Hospital | Bologna | Emilia-Romagna | 40133 | Italy | ||
| Policlinico S. Orsola |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Accuracy with which a pulmonologist can identify malignancy on ROSE samples | The outcome 3 will be measured by verifying the agreement between pulmonologist and pathologist, the latter being the gold standard | The time frame is the duration of each bronchoscopy endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled |
| Bologna |
| Italy |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |