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

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ClinicalTrials.gov Identifier: NCT00897273
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : September 16, 2010
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment
Head and Neck Cancer Infection Precancerous Condition 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

Detailed Description:


  • 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.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oral HPV Infection in Young Men
Study Start Date : May 2007
Primary Completion Date : May 2009

Primary Outcome Measures :
  1. Presence of an oral human papillomavirus (HPV) type 16, 18, 6 or 11 infection
  2. Presence of oral HPV infection by any of 37 HPV types

Biospecimen Retention:   Samples With DNA

Laboratory Methods:

Oral rinse sample:

Standard, well-validated assays will be used to detect HPV genomic DNA in oral exfoliated cells from the Scope oral rinse sample.

Serum sample:

Standard laboratory assays will be used to detect antibodies to HPV16 L1 viral capsid protein.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 21 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
A convenience sample of 500 men recruited from Baltimore-area college health centers (Johns Hopkins University, University of Maryland, or Towson University).


  • Currently enrolled at one of the following institutions:

    • Johns Hopkins University
    • University of Maryland
    • Towson University


  • Able to understand the procedures and the potential risks involved as determined by clinic staff


  • No prior Gardasil® off label

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897273

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Maura Gillison, MD, PhD Sidney Kimmel Comprehensive Cancer Center

ClinicalTrials.gov Identifier: NCT00897273     History of Changes
Other Study ID Numbers: JHOC-J0729, CDR0000554422
P30CA006973 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: September 2010

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
recurrent squamous cell carcinoma of the oropharynx
oropharyngeal cancer
oropharyngeal squamous cell carcinoma
precancerous condition
human papilloma virus infection

Additional relevant MeSH terms:
Communicable Diseases
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Precancerous Conditions
Papillomavirus Infections
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections