Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of 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.
Non Small Cell Lung Cancer
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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|
- Develop an integrated staging technique to detect early metastases in lung cancer which should affect patient outcomes more accurately than conventional staging techniques. [ Time Frame: Post operative ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Active Comparator: traditional mediastinoscopy/thoracoscopy
Traditional Mediastinoscopy used to detect or stage lung cancers.
Mediastinoscopy used to detect/stage lung cancer.
Other Name: Lung biopsy
Active Comparator: EBUS/EUS
Minimal invasive technique for staging/detecting lung cancer.
Minimal invasive technique to stage/detect 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970645
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425-6300|
|Study Chair:||Brenda Hoffman, M.D.||Medical University of South Carolina|
|Principal Investigator:||Eric S Edell, M.D.||Mayo Clinic, Rochester, MN|
|Principal Investigator:||Michael Wallace, M.D.||Mayo Clinic, Jacksonville, FL|