Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy
NCT ID: NCT01358097
Last Updated: 2014-04-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
33 participants
Study Classification
OBSERVATIONAL
Study Start Date
2010-10-31
Study Completion Date
2013-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Head and Neck Cancer
Oropharyngeal Cancer
Human Papillomavirus
Squamous Cell Cancer
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Patients with HPV positive tumors
No interventions assigned to this group
Patients with HPV negative tumors
No interventions assigned to this group
Control
No interventions assigned to this group
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Andrew Sikora, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai, Otolaryngology - Head and Neck Surgery
New York, New York, United States
Site Status
Countries
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United States
References
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Other Identifiers
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GCO 10-1219
Identifier Type: -
Identifier Source: org_study_id
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