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 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.
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Develop an integrated staging technique to detect early metastases in lung cancer which should affect patient outcomes more accurately than conventional staging techniques.
Brenda Hoffman, M.D.
Medical University of South Carolina
United States: Institutional Review Board
|Mayo Clinic||Rochester, Minnesota 55905|
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|
|Mayo Clinic||Jacksonville, Florida 32224|