The SPOT-HPV Study

Active, not recruiting

• Conditions: HPV Infection; HPV Positive Oropharyngeal Squamous Cell Carcinoma
• Interventions: Diagnostic Test: Salivary TTMV-HPV DNA Test; Diagnostic Test: Blood TTMV-HPV DNA Test

• Registration Number: NCT05524025
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-09-01
• Study Start: 2022-11-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2024-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Cohort: Any Adult With HPV-positive throat cancer	Salivary TTMV-HPV DNA Test	Participants will receive 1x Salivary and Blood TTMV-HPV DNA Test(s).
Control Cohort: Adult Male Without HPV-positive throat cancer	Blood TTMV-HPV DNA Test	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.
Control Cohort: Adult Male Without HPV-positive throat cancer	Salivary TTMV-HPV DNA Test	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Brigham & Woman's Hospital; 🇺🇸 Boston, Massachusetts, United States