The SPOT-HPV Study
Characterizing the Specificity and Sensitivity of Oral TTMV-HPV DNA Testing: The SPOT-HPV Study
1 other identifier
observational
360
1 country
2
Brief Summary
The purpose of this research is to evaluate a new test for oral HPV DNA in saliva ('oral rinse test').
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedStudy Start
First participant enrolled
November 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedJanuary 21, 2026
January 1, 2026
1.8 years
August 29, 2022
January 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Control Cohort: Adult Male Without HPV-positive throat cancer
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.
Case Cohort: Any Adult With HPV-positive throat cancer
Participants will receive 1x Salivary and Blood TTMV-HPV DNA Test(s).
Interventions
Mouthwash rinse
Blood test
Eligibility Criteria
Clinic schedules will be screened by the study team to identify eligible participants.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brigham & Woman's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Biospecimen
A small amount of oral rinse fluid will be banked for future use.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eleni M Rettig, MD
Brigham and Women's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 29, 2022
First Posted
September 1, 2022
Study Start
November 30, 2022
Primary Completion
September 1, 2024
Study Completion
January 1, 2026
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.