NCT05524025

The SPOT-HPV Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 360 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• HPV Infection
• HPV Positive Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Salivary TTMV-HPV DNA Test	Mouthwash rinse
DIAGNOSTIC_TEST	Blood TTMV-HPV DNA Test	Blood test

Timeline

• Start date: 2022-11-30
• Primary completion: 2024-09-01
• Completion: 2026-01-01
• First posted: 2022-09-01
• Last updated: 2026-01-21

Locations

2 sites across 1 country: United States