The SPOT-HPV Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05524025

Enrollment

360

Registered

2022-09-01

Start date

2022-11-30

Completion date

2026-01-01

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV Infection, HPV Positive Oropharyngeal Squamous Cell Carcinoma

Keywords

HPV Infection, HPV-positive throat cancer

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.

Interventions

DIAGNOSTIC_TESTSalivary TTMV-HPV DNA Test

Mouthwash rinse

DIAGNOSTIC_TESTBlood TTMV-HPV DNA Test

Blood test

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREleni M Rettig, MD

Brigham and Women's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026