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NCT05524025 Clinical Trial

The SPOT-HPV Study

HPV Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05524025
Other study ID # 22-377
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 30, 2022
Est. completion date September 1, 2025

Study information
Verified date April 2024
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 360
Est. completion date September 1, 2025
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Salivary TTMV-HPV DNA Test
Mouthwash rinse
• Blood TTMV-HPV DNA Test
Blood test

Locations
Country Name City State
United States Brigham & Woman's Hospital Boston Massachusetts
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

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