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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.
OBJECTIVES:
OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection.
Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sample Collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comparative genomic hybridization | Genetic | Collection of sputum, blood, urine, and a small amount of lung tissue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To quantitate the molecular changes during lung cancer development | As a part of the study nasal brushing specimens, sputum, blood, urine, and a small amount of other tissue will be collected during standard of care procedures (bronchial epithelial, trans-thoracic fine needle aspiration (FNA) and thoracentesis as part of patient work up. Clinical diagnosis is the primary goal of the procedure. All the research specimens are collected after the primary goal of the procedure is met. | After collection of designated samples |
| Measure | Description | Time Frame |
|---|---|---|
| Develop a method to diagnose and stage pre-invasive and invasive lesions | Use of proteomic techniques in the laboratory to find a method of diagnosing lung tissue as benign or malignant rather than relying on invasive open-chest surgery for a diagnosis | After collection of designated samples |
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Inclusion Criteria:
-All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.
Exclusion Criteria:
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People who may have lung cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanderbilt Ingram Clinical Trials Information Program | Contact | 1-800-811-8480 |
| Name | Affiliation | Role |
|---|---|---|
| Fabien Maldonado, MD | Vanderbilt-Ingram Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37212 | United States |
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| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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Blood, urine, nasal cells, sputum, bronchal epithelial cells, airway tissue, and lung tissue
| gene expression microarray analysis | Genetic | Collection of sputum, blood, urine, and a small amount of lung tissue. |
|
| proteomic profiling analysis | Genetic | Collection of sputum, blood, urine, and a small amount of lung tissue. |
|
| biologic sample preservation procedure | Other | Collection of sputum, blood, urine, and a small amount of lung tissue. |
|
| nasal brushing | Procedure | Using a brush, superficial cells are removed from the nose. |
|
| Blood draw | Procedure | Venous blood will be collected |
|
| Urine collection | Procedure | Subjects will be asked to provide a urine specimen. |
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| sputum sample | Procedure | Prior to their bronchoscopy, subjects will be asked for a sputum specimen. This is a collection of mucous that you cough up. |
|
| fluorescence bronchoscopy with airway biopsy | Procedure | A flexible tube attached to a fluorescent light source will be inserted into the subject's mouth or nose to reach the airway. Samples of the lining of the airway will be taken, as well as bronchial secretions and epithelial cell from brushings of the lining of the airway. |
|
| fine needle aspiration of the lung | Procedure | A small needle is inserted into the lung to collect tissue. This procedure will only be performed if the patient's physician orders it. |
|
| thoracentesis | Procedure | A small needle is inserted into the patient's lung cavity and a small amount of fluid is collected. This procedure will only be performed if the patient's physician orders it. |
|
| Veterans Affairs Medical Center - Nashville | Recruiting | Nashville | Tennessee | 37212 | United States |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D055028 | Comparative Genomic Hybridization |
| D020411 | Oligonucleotide Array Sequence Analysis |
| D001800 | Blood Specimen Collection |
| D059349 | Urine Specimen Collection |
| D000069258 | Thoracentesis |
| ID | Term |
|---|---|
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D025202 | Molecular Diagnostic Techniques |
| D009693 | Nucleic Acid Hybridization |
| D017421 | Sequence Analysis |
| D046228 | Microarray Analysis |
| D046208 | Microchip Analytical Procedures |
| D015336 | Molecular Probe Techniques |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D019152 | Paracentesis |
| D013812 | Therapeutics |
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