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NCT Number: NCT05524025

The SPOT-HPV Study

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

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Key information

Conditions

HPV Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases HPV Positive Oropharyngeal Squamous Cell Carcinoma Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham & Woman's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salivary TTMV-HPV DNA Test

Diagnostic Test

Mouthwash rinse

Blood TTMV-HPV DNA Test

Diagnostic Test

Blood test

Primary outcomes

  1. Prevalence of salivary TTMV-HPV DNA

    Time frame: 12 months

    Percentage of controls without cancer compared with percentage of cancer patients who have TTMV-HPV DNA detected in their saliva

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Sep 1, 2022
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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