Back to resultsHPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer
Primary Purpose
Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Obtaining Human tissue
Sponsored by
About this trial
This is an interventional diagnostic trial for Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx
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.
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm
Arm Description
Biosamples will be obtained at multiple time-points for all participants
Outcomes
Primary Outcome Measures
Number of subjects with Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT01984359
First Posted
November 8, 2013
Last Updated
April 9, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01984359
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Other
Arm Description
Biosamples will be obtained at multiple time-points for all participants
Intervention Type
Other
Intervention Name(s)
Obtaining Human tissue
Primary Outcome Measure Information:
Title
Number of subjects with Adverse Events
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Ahn, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer
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