The SPOT-HPV Study

Trial Title: The SPOT-HPV Study

NCT ID: NCT05524025

Condition: HPV Infection
HPV Positive Oropharyngeal Squamous Cell Carcinoma

Conditions: Official terms:
Papillomavirus Infections
Squamous Cell Carcinoma of Head and Neck

Conditions: Keywords:
HPV Infection
HPV-positive throat cancer

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Salivary TTMV-HPV DNA Test
Description: Mouthwash rinse
Arm group label: Case Cohort: Any Adult With HPV-positive throat cancer
Arm group label: Control Cohort: Adult Male Without HPV-positive throat cancer

Intervention type: Diagnostic Test
Intervention name: Blood TTMV-HPV DNA Test
Description: Blood test
Arm group label: Control Cohort: Adult Male Without HPV-positive throat cancer

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.

Criteria for eligibility:

Study pop:
Clinic schedules will be screened by the study team to identify eligible participants.

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Gender based: Yes

Gender description: Control cohort population is adult male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Brigham & Woman's Hospital

Address:
City: Boston
Zip: 02115
Country: United States

Facility:
Name: Dana Farber Cancer Institute

Address:
City: Boston
Zip: 02115
Country: United States

Start date: November 30, 2022

Completion date: September 1, 2025

Lead sponsor:
Agency: Dana-Farber Cancer Institute
Agency class: Other

Source: Dana-Farber Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05524025