Back to resultsMonitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)
Primary Purpose
Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assessment of Oral HPV Infection
Sponsored by
About this trial
This is an interventional other trial for Carcinoma, Squamous Cell focused on measuring Human Papilloma Virus, Oropharynx, Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma, Radiation Therapy, Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age (no upper age limit)
- AnyT, AnyN, M0 squamous cell carcinoma of the oropharynx
- Biopsy proven squamous cell carcinoma that is HPV positive via standard pathological assessment of tumor tissues in pathology department at the treating institution
- Scheduled for definitive CRT as primary treatment of their oropharynx cancer
Exclusion Criteria:
- Prior history of radiation therapy to the head and neck
- Prior history of mucosal head and neck cancer.
- Not willing or able to comply with study specific procedures
Sites / Locations
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Assessment of Oral HPV Infection
Arm Description
Oral HPV infection will be assessed 14 times, once prior to starting CRT, weekly during CRT, and then serially post-treatment: 4-8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months. Patients will provide samples of their saliva and exfoliated epithelial cells at these timepoints. Samples will be collected with supplies provided by and analyzed by OralDNA Labs.
Outcomes
Primary Outcome Measures
Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point
Secondary Outcome Measures
Time to HPV clearance for patients with HPV-positive OPSCC undergoing CRT
Number of aneuploidy cells as measured by FISH (Florescent in-situ hybridization) and the mRNA copy number for HPV E6 and HPV E7 at each time-point
Clinical outcomes of interest (local control, loco-regional control, distant metastasis-free survival, and overall survival (OS)) in patients with HPV-positive OPSCC undergoing CRT
Full Information
NCT ID
NCT02045186
First Posted
January 22, 2014
Last Updated
May 1, 2017
Sponsor
UNC Lineberger Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02045186
Brief Title
Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)
Official Title
Monitoring of Oral HPV Infection in HPV-positive Oropharyngeal Squamous Cell Carcinoma During and After Chemoradiotherapy (CRT)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to determine whether and when patients with human papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and chemotherapy clear their human papilloma virus infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms
Keywords
Human Papilloma Virus, Oropharynx, Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma, Radiation Therapy, Chemotherapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assessment of Oral HPV Infection
Arm Type
Other
Arm Description
Oral HPV infection will be assessed 14 times, once prior to starting CRT, weekly during CRT, and then serially post-treatment: 4-8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months. Patients will provide samples of their saliva and exfoliated epithelial cells at these timepoints. Samples will be collected with supplies provided by and analyzed by OralDNA Labs.
Intervention Type
Other
Intervention Name(s)
Assessment of Oral HPV Infection
Intervention Description
Saliva and exfoliated oral epithelial cells will be collected with collection supplies provided by OralDNA Labs. Patients will swish and gargle a saline solution for 30 seconds and expectorate it into a funneled collection tube. The collected specimen will be sent to OralDNA Labs. Three diagnostic tests will be performed on each sample to assess oral HPV infection:
Polymerase chain reaction (PCR) for HPV DNA.
Fluorescent in-situ hybridization (FISH).
Viral expression: The test is based on the measurement of the viral RNA levels by methods of detection of the fluorochrome labeled HPV probes by flow cytometry.
Primary Outcome Measure Information:
Title
Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point
Time Frame
2 years post-CRT of last enrolled patient
Secondary Outcome Measure Information:
Title
Time to HPV clearance for patients with HPV-positive OPSCC undergoing CRT
Time Frame
2 years post-CRT of last enrolled patient
Title
Number of aneuploidy cells as measured by FISH (Florescent in-situ hybridization) and the mRNA copy number for HPV E6 and HPV E7 at each time-point
Time Frame
2 years post-CRT of last enrolled patient
Title
Clinical outcomes of interest (local control, loco-regional control, distant metastasis-free survival, and overall survival (OS)) in patients with HPV-positive OPSCC undergoing CRT
Time Frame
2 years post-CRT of last enrolled patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years of age (no upper age limit)
AnyT, AnyN, M0 squamous cell carcinoma of the oropharynx
Biopsy proven squamous cell carcinoma that is HPV positive via standard pathological assessment of tumor tissues in pathology department at the treating institution
Scheduled for definitive CRT as primary treatment of their oropharynx cancer
Exclusion Criteria:
Prior history of radiation therapy to the head and neck
Prior history of mucosal head and neck cancer.
Not willing or able to comply with study specific procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhishamjit Chera, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill, Department of Radiation Oncology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)
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