The SPOT-HPV Study

Study Overview
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Brief Summary
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The purpose of this research is to evaluate a new test for oral HPV DNA in saliva ('oral rinse test').

Detailed Description
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This cross-sectional study will characterize the prevalence of salivary TTMV-HPV DNA among participants with and without HPV-positive throat cancer Oral HPV infection is common among healthy adult men, but most of these infections resolve spontaneously and only a very small percentage of oral HPV infections turn into HPV-positive throat cancer. This study is trying to understand whether this new oral rinse test detects HPV DNA from infection, cancer cells, or both. If this test is ONLY positive in people WITH cancer, it may be useful for diagnosing HPV-positive throat cancer in the future. Along with the oral rinse test study participants will complete brief surveys and participants with a positive salivary TTMV-HPV DNA tests may have repeat saliva testing, blood tests and head/neck exam. It is expected that about 360 people will take part in this research study. An external laboratory called Naveris is supporting this research study by providing testing for HPV DNA.

Official Title
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Characterizing the Specificity and Sensitivity of Oral TTMV-HPV DNA Testing: The SPOT-HPV Study

Conditions
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HPV Infection, HPV Positive Oropharyngeal Squamous Cell Carcinoma

Intervention / Treatment
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* Diagnostic Test: Salivary TTMV-HPV DNA Test
* Diagnostic Test: Blood TTMV-HPV DNA Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18+ years Able to provide informed consent Either one of the following: Control cohort: Male individuals WITHOUT head and neck tumors that are, or may be, HPV-positive Case cohort: Any individual WITH incident, untreated HPV-positive oropharynx squamous cell carcinoma Exclusion Criteria: Unable to provide informed consent Head and neck tumors of non-oropharynx subsites that are or may be HPV-positive, including oral cavity, sinonasal, laryngeal, hypopharyngeal, or nasopharyngeal squamous cell carcinomas

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Cohort: Adult Male Without HPV-positive throat cancer<br>Participants will receive 1x Salivary TTMV-HPV DNA Test. If test is negative there will not be follow up, if test is positive participants will have repeat Salivary TTMV-HPV DNA Test, a blood test and head and neck exam. | Diagnostic Test: Salivary TTMV-HPV DNA Test<br>* Mouthwash rinse<br>Diagnostic Test: Blood TTMV-HPV DNA Test<br>* Blood test<br>|
| Case Cohort: Any Adult With HPV-positive throat cancer<br>Participants will receive 1x Salivary and Blood TTMV-HPV DNA Test(s). | Diagnostic Test: Salivary TTMV-HPV DNA Test<br>* Mouthwash rinse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of salivary TTMV-HPV DNA | Percentage of controls without cancer compared with percentage of cancer patients who have TTMV-HPV DNA detected in their saliva | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV Infection, HPV-positive throat cancer