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

NCT ID: NCT01984359

Last Updated: 2020-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2018-05-24

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single arm

Biosamples will be obtained at multiple time-points for all participants

Group Type: OTHER

Obtaining Human tissue

Intervention Type: OTHER

Interventions

Obtaining Human tissue

Intervention Type: OTHER

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Ahn, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 22313

Identifier Type: -

Identifier Source: org_study_id