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Primary objective:
Secondary objective:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS FNA vs FNC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymph Node Needle Tissue Collections | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of times FNA and FNC agree on patient diagnosis (concordance) | 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
1. patients under 18 years or younger
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| Name | Affiliation | Role |
|---|---|---|
| Rodolfo C. Morice, MD | UT MD Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22156610 | Derived | Casal RF, Staerkel GA, Ost D, Almeida FA, Uzbeck MH, Eapen GA, Jimenez CA, Nogueras-Gonzalez GM, Sarkiss M, Morice RC. Randomized clinical trial of endobronchial ultrasound needle biopsy with and without aspiration. Chest. 2012 Sep;142(3):568-573. doi: 10.1378/chest.11-0692. |
| Label | URL |
|---|---|
| UT MD Anderson Cancer Center website | View source |
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| ID | Term |
|---|---|
| D000072281 | Lymphadenopathy |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D044963 | Biopsy, Fine-Needle |
| ID | Term |
|---|---|
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
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|
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D008919 | Investigative Techniques |