Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer

Status:	Archived
Conditions:	Lung Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	February 2010
End Date:	February 2011

A Prospective Multicenter Study Comparing Endobronchial and Endoscopic Ultrasound-Guided FNA to Mediastinoscopy/Thoracoscopy in the Staging and Early Detection of Metastases in Lung Cancer

This is a prospective randomized clinical trial with the study cohort comprised of all male
and female patients over the age of 21 presenting to the study site for evaluation of lung
cancer. The study will enroll 300 subjects, with 150 in each arm. Three sites will be in
the study, Mayo Rochester, Mayo Jacksonville and Medical University of South Carolina. Mayo
Rochester will enroll approximately 125 subjects. This study does not require subjects to
undergo any additional procedures than what they would receive per standard medical care.
The consenting subjects will receive EUS and /or EBUS- guided FNA or
Mediastinoscopy/Thoracoscopy.

This is a prospective randomized clinical trial of males and females age 21 or older being
evaluated for lung cancer. The study will enroll approximately 300 subjects (150 in each
arm) at 3 participating centers (MUSC, Mayo Clinic Rochester and Jacksonville). This sample
size will provide sufficient statistical power (i.e. >80%) using a non-inferiority study
design with 1-sided hypothesis testing (Farrington and Manning 1990) to determine whether or
not the sensitivity of the EUS/EBUS diagnostic technique is inferior (i.e. 10% or more
lower) when compared to the sensitivity of malignant mediastinal adenopathy of about 40%.
This study requires subjects to agree to the selection of their standard of care procedure.
Subjects will be randomized (stratified computer generated randomization stratified y center
and y CT positivity for pathologically enlarged [>1cm short axis] node - 10 strata).
Randomization will use variable block sizes (4-8), so that randomization allocation remains
concealed as investigators will not be blinded. This study requires subjects to consent to
the release of outcome data and follow-up data to be used for study analysis. No additional
visit will be required for this study; this study will not require any additional time
requirements beyond their scheduled evaluations.

We found this trial at

sites

Mayo Clinic - Division of Nephrology

Rochester, Minnesota 55905

from

Rochester, MN