The SPOT-HPV Study

Dana-Farber Cancer Institute

Status: Completed

Conditions: HPV Infection; HPV Positive Oropharyngeal Squamous Cell Carcinoma

Treatments: Diagnostic Test: Blood TTMV-HPV DNA Test; Diagnostic Test: Salivary TTMV-HPV DNA Test

Study type: Observational

Funder types: Other

Identifiers

NCT05524025

22-377

Details and patient eligibility

About

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

Full description

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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

360 participants in 2 patient groups

Control Cohort: Adult Male Without HPV-positive throat cancer

Description:

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.

Treatment:

Diagnostic Test: Salivary TTMV-HPV DNA Test

Diagnostic Test: Blood TTMV-HPV DNA Test

Case Cohort: Any Adult With HPV-positive throat cancer

Description:

Participants will receive 1x Salivary and Blood TTMV-HPV DNA Test(s).

Treatment:

Diagnostic Test: Salivary TTMV-HPV DNA Test