Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx
Conditions
Brief summary
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.
Interventions
OTHERObtaining Human tissue
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with Adverse Events | 4 years |
Countries
United States
Outcome results
None listed