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

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 ( 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.