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The purpose of this study is to investigate the role of the immune system in the response of squamous cell cancers of the head and neck to treatment that includes radiation therapy. Current research demonstrates that several natural immune cells and molecules affect the way the body's immune system interacts with a cancerous growth. Some cancers may be related to infection with a virus, such as the Human Papilloma Virus (HPV). Studying the activity of the immune system in head and neck cancers, especially cancers related to HPV infections, can provide valuable information to better understand the body's interaction with cancer cells.
This is a study of the immune response in patients with oropharyngeal cancer who undergo treatment with radiation, chemoradiation, or robotic surgery. Many oropharyngeal cancers are caused by infection with the human Papillomavirus (HPV), and patients with HPV-mediated tumors have much better prognosis and treatment response compared to patients with HPV-negative tumors. The investigators will test the hypothesis that radiation-based therapy of oropharyngeal cancer is associated with activation of the endogenous HPV-specific immune response. In this study the investigators will collect blood at several time points before, during, and after treatment to monitor the immune response in patients with tumors positive and negative for HPV versus normal healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with HPV positive tumors | |||
| Patients with HPV negative tumors | |||
| Control |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| HPV-specific T-cell response | at time of enrollment into study (baseline) | |
| HPV-specific T-cell response | after 3 weeks of treatment | |
| HPV-specific T-cell response for HPV+ tumors | 3 months after completion of treatment | |
| HPV-specific T-cell response for HPV+ tumors | 6 months after completion of treatment | |
| HPV-specific T-cell response | 1 year after completion of treatment | |
| HPV-specific T-cell response | 2 years after completion of treatment | |
| HPV-specific T-cell response | 3 years after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating immune cells and cytokines | at time of enrollment into study (baseline) | |
| Circulating immune cells and cytokines | after 3 weeks of treatment | |
| Circulating immune cells and cytokines |
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Inclusion Criteria:
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Patients with new head and neck cancer, who reside in the tri-state area.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Sikora, MD, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai, Otolaryngology - Head and Neck Surgery | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11668491 | Background | Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available. | |
| Background | American Cancer Society. Cancer Facts and Figures, 2007. Available at American Cancer Society, http://www.cancer.org. | ||
| 19330833 |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
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Serum, peripheral blood mononuclear cells
| 3 months after completion of treatment |
| Circulating immune cells and cytokines | 6 months after completion of treatment |
| Circulating immune cells and cytokines | one year after completion of treatment |
| Clinical outcome correlation | three years after treatment |
| inflammatory/regulatory cytokines | at time of enrollment (baseline) |
| inflammatory/regulatory cytokines | after 3 weeks of treatment |
| inflammatory/regulatory cytokines | 3 months after completion of treatment |
| inflammatory/regulatory cytokines | 6 months after completion of treatment |
| inflammatory/regulatory cytokines | 1 year after completion of treatment |
| serum nitrite/nitrate | after 3 weeks of treatment |
| serum nitrite/nitrate | 3 months after completion of treatment |
| serum nitrite/nitrate | 6 months after completion of treatment |
| serum nitrite/nitrate | 1 year after completion of treatment |
| Background |
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| D010608 |
| Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002277 | Carcinoma |