An observational study in Head and Neck Cancer, Oropharyngeal Cancer and Human Papillomavirus, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-10.
Sponsored by Icahn School of Medicine at Mount Sinai · Observational
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 33 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with new head and neck cancer, who reside in the tri-state area.
Exclusion Criteria:
HPV-specific T-cell response
Time frame: at time of enrollment into study (baseline)
HPV-specific T-cell response
Time frame: after 3 weeks of treatment
HPV-specific T-cell response for HPV+ tumors
Time frame: 3 months after completion of treatment
HPV-specific T-cell response for HPV+ tumors
Time frame: 6 months after completion of treatment
HPV-specific T-cell response
Time frame: 1 year after completion of treatment
HPV-specific T-cell response
Time frame: 2 years after completion of treatment
HPV-specific T-cell response
Time frame: 3 years after completion of treatment
Circulating immune cells and cytokines
Time frame: at time of enrollment into study (baseline)
Circulating immune cells and cytokines
Time frame: after 3 weeks of treatment
Circulating immune cells and cytokines
Time frame: 3 months after completion of treatment
Circulating immune cells and cytokines
Time frame: 6 months after completion of treatment
Circulating immune cells and cytokines
Time frame: one year after completion of treatment
Clinical outcome correlation
Time frame: three years after treatment
inflammatory/regulatory cytokines
Time frame: at time of enrollment (baseline)
inflammatory/regulatory cytokines
Time frame: after 3 weeks of treatment
inflammatory/regulatory cytokines
Time frame: 3 months after completion of treatment
inflammatory/regulatory cytokines
Time frame: 6 months after completion of treatment
inflammatory/regulatory cytokines
Time frame: 1 year after completion of treatment
serum nitrite/nitrate
Time frame: after 3 weeks of treatment
serum nitrite/nitrate
Time frame: 3 months after completion of treatment
serum nitrite/nitrate
Time frame: 6 months after completion of treatment
serum nitrite/nitrate
Time frame: 1 year after completion of treatment
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai