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

April 9, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with Adverse Events
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Peter Ahn, MD, Abramson Cancer Center of The University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

May 24, 2018

Study Registration Dates

First Submitted

November 8, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (Estimate)

November 14, 2013

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 22313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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