Head and Neck Cancer Clinical Trial
Official title:
Biomarkers of Immune Function as Predictors of Head and Neck Squamous Cell Carcinoma (HNSCC) in Response to Therapy
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - The patient has biopsy-proven squamous cell carcinoma, Stage II-IV, of the oropharynx or larynx. - The patient is to undergo treatment with radiation, chemo-radiation, or robotic surgery. - The patient is able to give informed consent. - The patient is at least 18 years old. - The patient's ECOG performance status is </=2. Exclusion Criteria: - The patient has had prior head and neck squamous cell carcinoma, with the exception of superficial cutaneous basal cell or squamous cell carcinomas. - The patient has active cancer in another part of the body, with the exception of superficial cutaneous basal cell or squamous cell carcinomas. - If a cancer survivor, the disease free interval is less than 5 years, with the exception of superficial cutaneous basal cell or squamous cell carcinomas. - The patient is a minor. - The patient is pregnant. - The patient is a prisoner. - The patient is incapable of understanding the consent process. - The patient has previously received definitive surgical, radiation, or chemoradiation treatment for HNSCC. - The patient has a history of HIV or other known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai, Otolaryngology - Head and Neck Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
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* Note: There are 51 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HPV-specific T-cell response | at time of enrollment into study (baseline) | No | |
Primary | HPV-specific T-cell response | after 3 weeks of treatment | No | |
Primary | HPV-specific T-cell response for HPV+ tumors | 3 months after completion of treatment | No | |
Primary | HPV-specific T-cell response for HPV+ tumors | 6 months after completion of treatment | No | |
Primary | HPV-specific T-cell response | 1 year after completion of treatment | No | |
Primary | HPV-specific T-cell response | 2 years after completion of treatment | No | |
Primary | HPV-specific T-cell response | 3 years after completion of treatment | No | |
Secondary | Circulating immune cells and cytokines | at time of enrollment into study (baseline) | No | |
Secondary | Circulating immune cells and cytokines | after 3 weeks of treatment | No | |
Secondary | Circulating immune cells and cytokines | 3 months after completion of treatment | No | |
Secondary | Circulating immune cells and cytokines | 6 months after completion of treatment | No | |
Secondary | Circulating immune cells and cytokines | one year after completion of treatment | No | |
Secondary | Clinical outcome correlation | three years after treatment | No | |
Secondary | inflammatory/regulatory cytokines | at time of enrollment (baseline) | No | |
Secondary | inflammatory/regulatory cytokines | after 3 weeks of treatment | No | |
Secondary | inflammatory/regulatory cytokines | 3 months after completion of treatment | No | |
Secondary | inflammatory/regulatory cytokines | 6 months after completion of treatment | No | |
Secondary | inflammatory/regulatory cytokines | 1 year after completion of treatment | No | |
Secondary | serum nitrite/nitrate | after 3 weeks of treatment | No | |
Secondary | serum nitrite/nitrate | 3 months after completion of treatment | No | |
Secondary | serum nitrite/nitrate | 6 months after completion of treatment | No | |
Secondary | serum nitrite/nitrate | 1 year after completion of treatment | No |
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