Biomarkers of Immune Function as Predictors of Head and Neck Squamous Cell Carcinoma (HNSCC) in Response to Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- HPV-specific T-cell response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
HPV-specific T-cell response
时间窗: 3 years after completion of treatment
HPV-specific T-cell response for HPV+ tumors
时间窗: 6 months after completion of treatment
次要结局
- Circulating immune cells and cytokines(one year after completion of treatment)
- serum nitrite/nitrate(1 year after completion of treatment)
- Clinical outcome correlation(three years after treatment)
- inflammatory/regulatory cytokines(1 year after completion of treatment)