Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
360 participants
OBSERVATIONAL
2022-11-30
2026-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Salivary TTMV-HPV DNA Test
Mouthwash rinse
Blood TTMV-HPV DNA Test
Blood test
Case Cohort: Any Adult With HPV-positive throat cancer
Participants will receive 1x Salivary and Blood TTMV-HPV DNA Test(s).
Salivary TTMV-HPV DNA Test
Mouthwash rinse
Interventions
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Salivary TTMV-HPV DNA Test
Mouthwash rinse
Blood TTMV-HPV DNA Test
Blood test
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Dana-Farber Cancer Institute
OTHER
Responsible Party
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Eleni Marie Rettig, MD
Principal Investigator
Principal Investigators
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Eleni M Rettig, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham & Woman's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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22-377
Identifier Type: -
Identifier Source: org_study_id
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