Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time

Study Overview
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Brief Summary
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This research is being done to understand more about a sexually transmitted virus called Human papillomavirus (HPV) in people with oropharyngeal cancer and their partners.

Detailed Description
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This study evaluates oral HPV infection and risk factors in people with head and neck cancer and their partners or spouses. The study focuses on oropharyngeal cancer patients and includes patients with HPV-associated and HPV-unassociated disease. A comparison group of people without cancer (controls) are also being enrolled. Couples are followed longitudinally and there is a repository of study samples. It is hoped that this research will help us understand risk factors for oral HPV infection, persistence and transmission as well as researching biomarkers for HPV-associated oral cancer and survival. The study is led by Dr Amber D'Souza (Johns Hopkins) and laboratory testing for the study is performed in the laboratory of study co-investigator Dr Maura Gillison (Ohio University). The study biorepository is led by Dr karen Anderson (Arizona State). Participants are being enrolled at four sites across the United States including: Mt Sinai (site PI Dr Marshall Posner), Johns Hopkins (site PI Dr Sara Pai), Dana Farber Cancer Institute (site PI Dr Robert Haddad) and Oregon Health and Science University (site PI Dr Neil Gross).

Official Title
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Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time

Conditions
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Oropharyngeal Cancer, Human Papillomavirus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older and incident oropharyngeal cancer Exclusion Criteria: Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent Cancer patients with a history of organ transplant, autoimmune disorder treated with steroids or immunosuppressive drug, lymphoma, leukemia or bone marrow transplant are also ineligible (partners with these conditions are eligible)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| oropharyngeal cancer case<br>208 oropharyngeal cancer cases were enrolled | |
| partner or spouse of case<br>110 partners of patients with oropharyngeal cancer were enrolled | |
| control<br>A convenience group of 106 non-cancer controls were enrolled at some study sites at cancer screening events | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV DNA detection in oral rinse sample | Detection of 17 types of HPV DNA in exfoliated oral cells of cases and partners collected using an oral rinse and gargle | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, HNSCC