Clinical trial NCT01984359: HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Number of subjects with Adverse Events
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Peter Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: