Spots Global Cancer Trial Database for The SPOT-HPV Study

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Trial Identification

Brief Title: The SPOT-HPV Study

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

Study ID: NCT05524025

Conditions

HPV Infection

HPV Positive Oropharyngeal Squamous Cell Carcinoma

Interventions

Salivary TTMV-HPV DNA Test

Blood TTMV-HPV DNA Test

Study Description

Brief 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.