Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms
Conditions
Keywords
Human Papilloma Virus, Oropharynx, Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma, Radiation Therapy, Chemotherapy
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.
Interventions
OTHERAssessment of Oral HPV Infection
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: 1. Polymerase chain reaction (PCR) for HPV DNA. 2. Fluorescent in-situ hybridization (FISH). 3. 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.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age (no upper age limit) 2. AnyT, AnyN, M0 squamous cell carcinoma of the oropharynx 3. Biopsy proven squamous cell carcinoma that is HPV positive via standard pathological assessment of tumor tissues in pathology department at the treating institution 4. Scheduled for definitive CRT as primary treatment of their oropharynx cancer
Exclusion criteria
1. Prior history of radiation therapy to the head and neck 2. Prior history of mucosal head and neck cancer. 3. Not willing or able to comply with study specific procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point | 2 years post-CRT of last enrolled patient |
Secondary
| Measure | Time frame |
|---|---|
| Time to HPV clearance for patients with HPV-positive OPSCC undergoing CRT | 2 years post-CRT of last enrolled patient |
| 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 | 2 years post-CRT of last enrolled patient |
| 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 | 2 years post-CRT of last enrolled patient |
Countries
United States
Outcome results
None listed