HPV InfectionNCT05524025
The SPOT-HPV Study
An observational study of HPV Infection and HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this research is to evaluate a new test for oral HPV DNA in saliva ('oral rinse test'). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, HPV Positive Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Salivary TTMV-HPV DNA Test and Blood TTMV-HPV DNA Test
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2022to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clinic schedules will be screened by the study team to identify eligible participants.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham & Woman's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Characterizing the Specificity and Sensitivity of Oral TTMV-HPV DNA Testing: The SPOT-HPV Study
The purpose of this research is to evaluate a new test for oral HPV DNA in saliva ('oral rinse test').
Read the 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.
- Being tested
- Salivary TTMV-HPV DNA Test, Blood TTMV-HPV DNA Test
- Keywords
- HPV Infection, HPV-positive throat cancer
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary TTMV-HPV DNA TestDiagnostic test
Mouthwash rinse
Blood TTMV-HPV DNA TestDiagnostic test
Blood test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Salivary TTMV-HPV DNA Test; Diagnostic Test: Blood TTMV-HPV DNA Test | |
| Case Cohort: Any Adult With HPV-positive throat cancer | Participants will receive 1x Salivary and Blood TTMV-HPV DNA Test(s). Receives: Diagnostic Test: Salivary TTMV-HPV DNA Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start30 Nov 2022
- Primary completion1 Sep 2024
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleni Marie Rettig, MD, Dana-Farber Cancer Institute
- Investigators
- Eleni M Rettig, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524025
- Sponsor's protocol ID
- 22-377
- Status last verified
- Jan 2026
- First submitted
- 29 Aug 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Specificity and Sensitivity of Oral TTMV-HPV DNA Testing: The SPOT-HPV Study
- ClinicalTrials.gov ID
- NCT05524025
- Acronym / sponsor ID
- 22-377
- Keywords
- HPV Infection, HPV-positive throat cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Cohort: Adult Male Without HPV-positive throat cancer | – | Diagnostic Test: Salivary TTMV-HPV DNA Test, Diagnostic Test: Blood TTMV-HPV DNA TestParticipants 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 | – | Diagnostic Test: Salivary TTMV-HPV DNA TestParticipants will receive 1x Salivary and Blood TTMV-HPV DNA Test(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic schedules will be screened by the study team to identify eligible participants.
Key inclusion criteria (5 listed)
- Age 18+ years
- Able to provide informed consent
- Either one of the following:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary TTMV-HPV DNA TestMouthwash rinse | Diagnostic test | Case Cohort: Any Adult With HPV-positive throat cancer, Control Cohort: Adult Male Without HPV-positive throat cancer |
| Blood TTMV-HPV DNA TestBlood test | Diagnostic test | Control Cohort: Adult Male Without HPV-positive throat cancer |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleni M Rettig, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infection and HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of salivary TTMV-HPV DNA (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.