Can a Pulmonologist Reliably Assess the Tumor Burden on ROSE Slides Obtained From Pulmonary Nodules and Lymphadenopathy

Lung Cancer Clinical Trial

Official title:

Interobserver Agreement Between Pulmonologist, Pathologist and Molecular Pathologist in the Assessment of Tumor Burden on ROSE Slides Obtained With Endoscopic Procedures From Pulmonary Nodules and Intrathoracic Lymphadenopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845764
• Other study ID #: Bio-Pulmo-ROSE
• Status: Completed
• Start date: February 18, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: August 2019
• Source: Maggiore Bellaria Hospital, Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: July 30, 2019
• Est. primary completion date: June 30, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lymphadenopathy
• Multiple Pulmonary Nodules

Intervention

Diagnostic Test:
• Rapid 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

Locations

Country	Name	City	State
Italy	Maggiore Hospital	Bologna	Emilia Romagna
Italy	Policlinico S. Orsola	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Maggiore Bellaria Hospital, Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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