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

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01984359

Collaborator

(none)

Enrollment

Location

Arm

60.7

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx	Other: Obtaining Human tissue	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

May 24, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Single arm

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

Other: Obtaining Human tissue

Outcome Measures

Primary Outcome Measures

Number of subjects with Adverse Events [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01984359

Other Study ID Numbers:

UPCC 22313

First Posted:

Nov 14, 2013

Last Update Posted:

Apr 10, 2020

Last Verified:

Apr 1, 2020

Additional relevant MeSH terms:

Carcinoma

Head and Neck Neoplasms

Oropharyngeal Neoplasms

Study Results

No Results Posted as of Apr 10, 2020