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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00970645
Other study ID # 09-002240
Secondary ID DOD protocol A-1
Status Terminated
Phase N/A
First received September 1, 2009
Last updated July 15, 2011
Start date February 2010
Est. completion date March 2011

Study information

Verified date July 2011
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Age 21 years or greater

- Pt is a surgical candidate for mediastinoscopy, thoracoscopy, or lung resection

- Known or suspected non-small cell carcinoma of the lung eligible for resection

- CT scan performed within 45 days prior to evaluation for study participation

- PET scan performed within 45 days prior to evaluation for study participation

Exclusion Criteria:

- Pathologically proven metastatic disease

- History of malignancy within 5 years other than (skin) basal cell carcinoma

- Enlarged ipsilateral mediastinal lymph nodes > 2.5 cm in diameter

- Peripheral T1 tumors with normal mediastinal lymph nodes on CT and PET

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Procedure:
Mediastinoscopy/thoracoscopy
Mediastinoscopy used to detect/stage lung cancer.
EBUS/EUS
Minimal invasive technique to stage/detect lung cancer.

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States Mayo Clinic Jacksonville Florida
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Develop an integrated staging technique to detect early metastases in lung cancer which should affect patient outcomes more accurately than conventional staging techniques. Post operative No
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