Oral HPV Infection in Young Men

Study Overview
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Brief Summary
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RATIONALE: Gathering information about human papillomavirus infection of the mouth in young men may help doctors learn more about risk factors for oropharyngeal cancer. PURPOSE: This research study is assessing human papillomavirus infection of the mouth in young men and risk factors for oropharyngeal cancer.

Detailed Description
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OBJECTIVES: Estimate the prevalence of oral human papillomavirus (HPV) type 16, 18, 6, or 11 infection in young adult men. Assess the independent effect of distinct sexual practices, including kissing, oral sex, and vaginal intercourse, on oral HPV prevalence. Estimate the 6-month incidence of HPV infection in this study population. OUTLINE: Participants are assessed for oral human papillomavirus virus (HPV) infection (i.e., types 16, 18, 6, and 11) and for known or potential risk factors associated with the infection, including sexual behavior (e.g., kissing, performing oral sex, or vaginal intercourse), demographic characteristics (e.g., age or race), and history of HPV or other sexually transmitted infections. Prior exposure to HPV vaccine is also assessed. Oral rinse samples are collected from participants at baseline and at 6 months for detection of HPV genomic DNA in oral exfoliated cells. Baseline serum samples are also collected.

Official Title
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Human Papillomavirus Infection of the Mouth in Young Men and Risk Factors for Oropharyngeal Cancer

Conditions
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Head and Neck Cancer, Infection, Precancerous Condition

Intervention / Treatment
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* Genetic: comparative genomic hybridization
* Genetic: gene expression analysis
* Other: study of socioeconomic and demographic variables
* Procedure: evaluation of cancer risk factors
* Procedure: study of high risk factors


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Currently enrolled at one of the following institutions: Johns Hopkins University University of Maryland Towson University PATIENT CHARACTERISTICS: Able to understand the procedures and the potential risks involved as determined by clinic staff PRIOR CONCURRENT THERAPY: No prior Gardasil® off label

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Male

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

| Intervention/Treatment |
| --- |
|Genetic: comparative genomic hybridization|nan|
|Genetic: gene expression analysis|nan|
|Other: study of socioeconomic and demographic variables|nan|
|Procedure: evaluation of cancer risk factors|nan|
|Procedure: study of high risk factors|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of an oral human papillomavirus (HPV) type 16, 18, 6 or 11 infection |  | 2 years | 
| Presence of oral HPV infection by any of 37 HPV types |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent squamous cell carcinoma of the oropharynx, oropharyngeal cancer, oropharyngeal squamous cell carcinoma, infection, precancerous condition, human papilloma virus infection