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
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oral HPV Infection in Young Men

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

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.


Estimated Enrollment: 500
Study Start Date: May 2007
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 21 Years
Genders 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).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897273

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Maura Gillison, MD, PhD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00897273     History of Changes
Other Study ID Numbers: JHOC-J0729, CDR0000554422, P30CA006973, JHOC-J0729, JHOC-_NA_00009472
Study First Received: May 9, 2009
Last Updated: September 15, 2010
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 16, 2014