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

Not Applicable

Completed

• Conditions: Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx
• Interventions: Other: Obtaining Human tissue

• Registration Number: NCT01984359
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-14
• Primary Completion: 2015-12
• Study Completion: 2018-05-24
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Obtaining Human tissue	Biosamples will be obtained at multiple time-points for all participants

Primary Outcome Measures

Name	Time	Method
Number of subjects with Adverse Events	4 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States