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| Tracking Information | |||||
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| First Received Date ICMJE | November 14, 2007 | ||||
| Last Updated Date | October 22, 2009 | ||||
| Start Date ICMJE | October 2007 | ||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number Patients Restaged Upwards by Mediastinoscopy Following EBUS Evaluation [ Time Frame: 2 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EBUS-FNA and mediastinoscopy in identifying mediastinal nodal metastases. [ Time Frame: 14 Months ] | ||||
| Change History | Complete list of historical versions of study NCT00559611 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Endobronchial Ultrasound Versus Mediastinoscopy in Patients With Non-Small Cell Lung Cancer (NSCLC) | ||||
| Official Title ICMJE | Prospective Comparison of Endobronchial Ultrasound Needle Biopsy Versus Mediastinoscopy for Staging of Mediastinal Nodes in Patients With Clinical Stage IIIA Non-Small Cell Lung Cancer (NSCLC) | ||||
| Brief Summary | The aim of this prospective study is to determine the staging accuracy of endobronchial ultrasound guided fine needle aspiration biopsy of mediastinal lymph nodes compared to the 'gold standard', mediastinoscopy, in patients with clinical Stage IIIA non-small cell lung cancer. Primary Objective: 1. To determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EBUS-FNA and mediastinoscopy in identifying mediastinal nodal metastases. Secondary Objectives:
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| Detailed Description | The current procedure used to check for cancer cells in the lungs is a small operation at the base of the neck (mediastinoscopy) to get samples of the lymph glands. These samples are then looked at under the microscope to see if they contain cancer cells. A procedure has been developed that may allow doctors to get samples of lymph glands without having to perform an operation. This is called endobronchial ultrasound or "EBUS". The purpose of this study is to compare the 2 procedures. If you agree to take part in this study, your insurance provider will be contacted. In order for you to take part in this study, your insurance provider must agree to pay for both the EBUS and mediastinoscopy procedures. If your insurance provider agrees to pay for both procedures, you will be scheduled for the EBUS and a mediastinoscopy. The procedures will not be scheduled on the same day. You will first have the EBUS. You will receive general anesthesia and a small flexible scope will be passed down your windpipe. Samples of your lymph gland tissue will then be collected through a tiny needle that is passed through the scope. This will be performed as an out patient procedure. If a tumor is found on the opposite side of your chest from another tumor by the EBUS, a mediastinoscopy will not be necessary. If a tumor is not found on the opposite side of your chest from another tumor by the EBUS, you will then have a mediastinoscopy. This is also an outpatient procedure that will involve a small (2 cm) cut at the base of the neck, just above the breast bone. Your doctor will then pass a special scope with a camera into your chest (below the breast bone). This will allow your doctor to see the lymph glands around your windpipe and get samples of them. This will also be performed under general anesthesia and you will be able to leave the hospital shortly after the procedure. Depending on whether or not the lymph glands have cancer in them, your doctor will then recommend the best therapy for the tumor to you. This is an investigational study. The EBUS is FDA approved. The mediastinoscopy is considered standard of care. The comparison of the 2 procedures is investigational. Up to 100 patients will be take part in this study. All will be enrolled at M. D. Anderson. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment | ||||
| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00559611 | ||||
| Responsible Party | David C. Rice, MD/Associate Professor, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | 2007-0353 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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