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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: Rapid on-site evaluation

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • Policlinico S. Orsola
  • Emilia Romagna
    • Bologna, Emilia Romagna, Italy, 40133
      • Maggiore Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with indication to bronchoscopy or endosonography for suspected lung cancer based on imaging (CT and/or PET)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Maggiore Bellaria Hospital, Bologna
• Investigators: Principal Investigator: Rocco Trisolini, MD, Policlinico S. Orsola, Bologna

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: February 16, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lymphatic Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Lymphadenopathy
• Other Study ID Numbers: Bio-Pulmo-ROSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No