Evaluation of Endobronchial Ultrasound (EBUS) for Staging Lung Cancer (EBUS)

March 19, 2019 updated by: Ottawa Hospital Research Institute

This study will compare two different methods of staging lung cancer to determine whether endobronchial ultrasound (EBUS) staging of mediastinal lymph nodes will provide good diagnostic yield in detecting lung cancer, when compared to current methods of a staging bronchoscopy and cervical mediastinoscopy.

Study Overview

Status

Completed

Conditions

Lung Cancer

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Ottawa, Ontario, Canada, K1H8L6
    - Ottawa Hospital Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing a staging procedure for lung cancer (either cervical mediastinoscopy or endobronchial ultrasound).

Description

Inclusion Criteria:

Patients, > 18 years of age,

Gender- Males and Female

Diagnosis of Non Small Cell Lung Cancer.

Patients who have consented on an Ottawa Hospital consent form to undergo a mediastinoscopy procedure or EBUS-TBNA, and a Positron emission tomography (PET) of the chest for lung cancer staging.

Exclusion Criteria:

Females who are pregnant (or found to be pregnant) during the course of this research study.

Patients who do not provide their Ottawa Hospital consent to undergo a staging bronchoscopy , cervical mediastinoscopy or EBUS-TBNA.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cervical mediastinoscopy This group will undergo cervical mediastinoscopy before surgery to stage their lung cancer (procedure decided by the surgeon).
Endo-bronchial ultrasound This group will undergo endobronchial ultrasound before surgery to stage their lung cancer (procedure decided by the surgeon).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung cancer staging Time Frame: Pre-op and post-op	Lung cancer staging (assessed by either cervical mediastinoscopy or EBUS) will be compared both pre-op and post-op.	Pre-op and post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

Principal Investigator: Donna E Maziak, MD, MSc, Ottawa Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria