Lung Cancer
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTRapid on-site evaluation
Specimens obtained with endoscopic sampling procedures are stained with a rapid method (i.e., Diff Qui) and submitted to on-site cytologic review
Sponsors
Maggiore Bellaria Hospital, Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Age \> 18 years * Indication for endoscopic sampling of suspected malignant lymphadenopathy or pulmonary lesion * Written informed consent
Exclusion criteria
* High risk conditions for the performance of bronchoscopy and/or EBUS-TBNA * High risk condition for deep sedation (ASA 4) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy with which a pulmonologist can assess the tumor burden on ROSE slides | The time frame is the duration of each bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interobserver agreement between pulmonologist, pathologist and molecular pathologist in then assessment of the tumor burden on ROSE slides | The time frame is the duration of each bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled | The outcome 2 will be measured by verifying the agreement between the 3 professionals, using the judgment of the molecular pathologist as gold standard |
| Accuracy with which a pulmonologist can identify malignancy on ROSE samples | The time frame is the duration of each bronchoscopy endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for each patient enrolled | The outcome 3 will be measured by verifying the agreement between pulmonologist and pathologist, the latter being the gold standard |
Countries
Italy
Outcome results
None listed