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

NCT03845764 | Completed

• 1 other identifier: Bio-Pulmo-ROSE
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

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

Rapid on-site evaluation (ROSE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age \> 18 years
• Indication for endoscopic sampling of suspected malignant lymphadenopathy or pulmonary lesion
• Written informed consent

You may not qualify if:

• High risk conditions for the performance of bronchoscopy and/or EBUS-TBNA
• High risk condition for deep sedation (ASA 4)
• Pregnancy

Sponsors & Collaborators

• Maggiore Bellaria Hospital, Bologna: lead

Study Sites (2)

Maggiore Hospital

Bologna, Emilia-Romagna, 40133, Italy

Location

Policlinico S. Orsola

Bologna, Italy

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Rocco Trisolini, MD

  Policlinico S. Orsola, Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Interventional Pulmonology Unit

Study Record Dates

• First Submitted: February 16, 2019
• First Posted: February 19, 2019
• Study Start: February 18, 2019
• Primary Completion: June 30, 2019
• Study Completion: July 30, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)