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
500 participants
OBSERVATIONAL
2007-05-31
2009-05-05
Brief Summary
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PURPOSE: This research study is assessing human papillomavirus infection of the mouth in young men and risk factors for oropharyngeal cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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comparative genomic hybridization
gene expression analysis
study of socioeconomic and demographic variables
evaluation of cancer risk factors
study of high risk factors
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
21 Years
MALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Maura Gillison, MD, PhD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
References
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Gillison ML. Human papillomavirus-related diseases: oropharynx cancers and potential implications for adolescent HPV vaccination. J Adolesc Health. 2008 Oct;43(4 Suppl):S52-60. doi: 10.1016/j.jadohealth.2008.07.002.
Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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NA_00009472
Identifier Type: OTHER
Identifier Source: secondary_id
JHOC-J0729
Identifier Type: -
Identifier Source: secondary_id
CDR0000554422
Identifier Type: OTHER
Identifier Source: secondary_id
J0729
Identifier Type: -
Identifier Source: org_study_id
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