Mutational Analysis of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Specimens in Patients With Advanced Non-small Cell Lung Cancer: a Randomized Trial of Rapid On-site Evaluation

Maggiore Bellaria Hospital, Bologna1 site in 1 country126 target enrollmentFebruary 2013

ConditionsNon-small Cell Lung Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-small Cell Lung Cancer
Sponsor: Maggiore Bellaria Hospital, Bologna
Enrollment: 126
Locations: 1
Primary Endpoint: Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples can increase the percentage of patients with advanced non-squamous non-small cell lung cancer in whom both pathologic subtyping and mutational analysis are obtained.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

October 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maggiore Bellaria Hospital, Bologna

Responsible Party

Principal Investigator

Rocco Trisolini

M.D.

Maggiore Bellaria Hospital, Bologna

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years
•Suspected hilar or mediastinal lymph node metastasis from lung cancer

Exclusion Criteria

•Pregnancy
•Uncontrolled coagulopathy
•Refusal to sign informed consent

Outcomes

Primary Outcomes

Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes

Time Frame: 18 months

Percentage of patients for whom the mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes on EBUS-TBNA samples is obtained