HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer

A Pilot, Single-Center Study Of Quantitative HPV Serum Or Plasma DNA As A Prognostic Marker In P16+/HPV+ Squamous Carcinomas Of The Oropharynx And Unknown Primary Head And Neck Cancers

To assess in an exploratory manner, the pronostic utility for locoregional control, progression-free and distant metastasis-free survival of a pre-therapy and post-therapy blood DNA test of HPV E6 and E7 DNA for subtypes 16 and 18 in p16+ and/or HPV+ oropharyngeal cancer patients. This will entail analysis of both initial pre-therapy HPV level as a continuous variable and initial post-therapy HPV level as a dichotomous variable.

Inclusion Criteria:

• Histoloically proven primary cancer of the oropharynx, p16(+) and/or HPV (+), who are planned for treatment with resection, radiation and/or chemotherapy.
• Subsites of oropharynx:include tonsil, base of tongue, vallecula, oropharyngeal wall, soft palate, glossotonsillar sulcus.
• No or minimal smoking history (</= 10 pack-year, no smoking in the past 12 months last 10 years based on documented history and/or subject report)
• Age 18 years or older
• Subjects are capable of giving informed consent or have an acceptabl;e surrogate capable of giving consent on the subjects behalf.
• Enrollment on any other study, regardless of therapy is allowed.
• Enrollment on any other tumor or tissue banking study is allowed.
• Patients who have had blood drawn as part of another study, including the IRB-approved ENT Tumor Bank Study, may be included in this study even if the patient has already had surgery.

Exclusion Criteria:

• Previous chemotherapy or radiation therapy to the head and neck unrelated to current disease.
• Previous surgery for head and neck cancer unrelated to current disease.
• Widespread , biopsy-proven metastatic disease (stage IVC disease) at time of presentation (small indeterminate lung or mediastinal nodules are allowed)
• Patients who have started induction chemotherapy prior to consideration for study eligibility.
• Another active cancer except nonmelanomatous skin cancer.
• History of cervical penile or anal cancer.
• Patient treated with surgery, adjuvant radiation therapy or chemotherapy outside of the University of Pennsylvania.
• History of smoking in the past last 12 months 10 years
• History of 10 pack-years of cigarette smoking based on documented history and/or subject report
• Presence of sidespread leukoplakia or erythroplakia.