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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx

Intervention / Treatment
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* Other: Obtaining Human tissue


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>Biosamples will be obtained at multiple time-points for all participants | Other: Obtaining Human tissue<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Adverse Events |  | 4 years |