Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Study Overview
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Brief Summary
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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.

Official Title
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Monitoring of Oral HPV Infection in HPV-positive Oropharyngeal Squamous Cell Carcinoma During and After Chemoradiotherapy (CRT)

Conditions
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Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms

Intervention / Treatment
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* Other: Assessment of Oral HPV Infection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Assessment of Oral HPV Infection<br>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. | Other: Assessment of Oral HPV Infection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papilloma Virus, Oropharynx, Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma, Radiation Therapy, Chemotherapy