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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00897273
First received: May 9, 2009
Last updated: September 15, 2010
Last verified: September 2010

May 9, 2009
September 15, 2010
May 2007
May 2009   (final data collection date for primary outcome measure)
  • Presence of an oral human papillomavirus (HPV) type 16, 18, 6 or 11 infection [ Designated as safety issue: No ]
  • Presence of oral HPV infection by any of 37 HPV types [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00897273 on ClinicalTrials.gov Archive Site
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Human Papillomavirus Infection of the Mouth in Young Men and Risk Factors for Oropharyngeal Cancer
Oral HPV Infection in Young Men

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

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.

Probability Sample

A convenience sample of 500 men recruited from Baltimore-area college health centers (Johns Hopkins University, University of Maryland, or Towson University).

  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
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May 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 21 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00897273
JHOC-J0729, CDR0000554422, P30CA006973, JHOC-J0729, JHOC-_NA_00009472
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Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Maura Gillison, MD, PhD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP