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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00886847 |
Purpose
Primary objective:
Secondary objective:
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Procedure: Lymph Node Needle Tissue Collections |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Efficacy Study |
| Official Title: | Specimen Adequacy and Diagnostic Agreement of Fine Needle Aspiration (FNA) VS. Fine Needle Capillary Sampling (FNC) of Endobronchial Ultrasound-Guided Biopsy of Mediastinal Lymph Nodes |
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| EBUS FNA vs FNC: Experimental |
Procedure: Lymph Node Needle Tissue Collections
Total of two lymph nodes sampled per patient. Four biopsies will be taken from each lymph node. Two with suction (FNA) and two without suction (FNC).
|
Tissue Sample Collection:
If you agree to take part in this study, you will have your already scheduled endobronchial ultrasound-guided biopsy performed after you have been given a drug to make you sleep. You will be asked to sign a separate informed consent for the biopsy procedure.
During a standard of care biopsy procedure, there are normally 3-5 tissue sample collections performed. For the purposes of this study, you will have a total of 4 tissue collections performed during the biopsy procedure. Two tissue collections (2) using the FNC method, and 2 tissue collections using the FNA method.
If the first 4 tissue sample collections do not provide good enough tissue samples to perform the diagnosis, additional sample collections may be performed. If more samples are collected, these samples will not be used for the purposes of this study and will only be collected for diagnostic purposes.The sampling will be done by the pulmonologist who is performing your procedure.
The first 4 tissue samples that are collected for the purposes of this study will be examined to determine the quality of the sample as well as for diagnostic purposes.
Medical Record Information:
Information from your medical record will be collected 1 time for this study. The information collected will include information about your diagnosis, the number of radiation treatments you may have had, and additional information about your medical history. The information will be de-identified and stored in a research database on a password protected computer that only the study doctor and study staff will have access to.
Length of Study:
You will remain on study for the duration of biopsy procedure. After the biopsy has been performed, and your medical record information has been collected you will no longer be on study.
This is an investigational study. The endobronchial ultrasound-guided biopsy of the lymph nodes is FDA approved. Both methods of tissue collection (FNA and FNC) are FDA approved for the purposes of this study.
Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1. patients under 18 years or younger
Contacts and Locations| Contact: Rodolfo C. Morice, MD | 713-563-4257 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77007 | |
| Principal Investigator: Rodolfo C. Morice, MD | |
| Study Chair: | Rodolfo C. Morice, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Rodolfo C. Morice, MD / Professor ) |
| Study ID Numbers: | 2009-0051 |
| Study First Received: | April 21, 2009 |
| Last Updated: | April 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00886847 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Lung Cancer Enlarged hilar or/and mediastinal lymph andenopathy Benign Malignant Mediastinal lymph nodes Hilar lymph nodes Fine Needle Aspiration |
FNA Fine Needle Capillary Sampling FNC Endobronchial Ultrasound-Guided Biopsy EBUS Tissue Sample Suction |
|
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
