HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer
Conditions
Subjects With p16+/HPV+ Squamous Cell Carcinomas of the Oropharynx.
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms - Oropharyngeal Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Primary Purpose: Diagnostic
Intervention
Name: Obtaining Human tissue
Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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 smaoking history (=10 pack-year, no smoking in the 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 last 10 years.

- History of 10 pack-years of cigarette smoking based on documented history and/or subject report

- Presence of sidespread leukoplakia or erythroplakia.
Location
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Peter Ahn, MD - 855-216-0098 - PennCancerTrials@emergingmed.com
Start Date
May 2013
Completion Date
May 2017
Sponsors
Abramson Cancer Center of the University of Pennsylvania
Source
Abramson Cancer Center of the University of Pennsylvania
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page