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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-HN-0715 | |||
| VU-VICC-070668 |
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study closed prematurely upon PI's departure from VICC
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how will patients respond to treatment.
PURPOSE: This research study is looking at gene and protein expression patterns in predicting response to cetuximab in patients with recurrent and/or metastatic head and neck cancer.
OBJECTIVES:
OUTLINE: Tumor tissue specimens and clinical data are obtained from the Head and Neck Tumor Tissue Repository and Clinical Database protocol VU-VICC-HN-0356. Specimens are analyzed for patterns of gene and protein expression predictive of cetuximab treatment response and survival by DNA microarray, tissue microarray, reverse transcriptase-PCR, and mass spectroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| head and neck cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA and tissue microarray analysis | Genetic | The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression. |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of 100 patients from the Head and Neck (H&N) Tumor Tissue Repository and Clinical Database treated with cetuximab or cetuximab-containing combination therapy as a standard of care | approximately three years from enrollment of first patient | |
| Gene and protein expression patterns in selected H&N Tumor Tissue Repository and Clinical Database patients | upon colleciton of final patient data | |
| Predictive patterns of gene and protein expression associated with cetuximab treatment response and survival | upon collection of final patient data |
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DISEASE CHARACTERISTICS:
Diagnosis of recurrent and/or metastatic head and neck squamous cell carcinoma
Sufficient biological material available for analysis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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head and neck cancer patients
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Murphy, MD | Vanderbilt-Ingram Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37064 | United States | ||
| Vanderbilt-Ingram Cancer Center at Franklin |
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| reverse transcriptase-polymerase chain reaction | Genetic | The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression. |
|
| mass spectrometry | Other | The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression. |
|
| Nashville |
| Tennessee |
| 37064 |
| United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D012468 | Salivary Gland Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
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| ID | Term |
|---|---|
| D004247 | DNA |
| D046888 | Tissue Array Analysis |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D013058 | Mass Spectrometry |
| ID | Term |
|---|---|
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D046228 | Microarray Analysis |
| D046208 | Microchip Analytical Procedures |
| D008919 | Investigative Techniques |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D002623 | Chemistry Techniques, Analytical |
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