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

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.

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

Control cohort population is adult male

Clinic schedules will be screened by the study team to identify eligible participants.

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Data can be shared no earlier than 1 year following the date of publication

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu