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

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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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maggiore Hospital, Bologna, Emilia-Romagna, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Accuracy with which a pulmonologist can assess the tumor burden on ROSE slides

Time frame: 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 outcomes

Interobserver agreement between pulmonologist, pathologist and molecular pathologist in then assessment of the tumor burden on ROSE slides

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Maggiore Bellaria Hospital, Bologna

Other

Registry information

Official study 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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Feb 19, 2019
Registry last updated: Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed