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

Maggiore Bellaria Hospital, Bologna

Status: Completed

Conditions: Lung Cancer

Treatments: Diagnostic Test: Rapid on-site evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT03845764

Bio-Pulmo-ROSE

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

164 participants in 1 patient group

Rapid on-site evaluation (ROSE)

Description:

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

Treatment:

Diagnostic Test: Rapid on-site evaluation