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OpenTrials
Completed

NCT Number: NCT00897273

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Head and Neck Neoplasms Infection Infections Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Precancerous Condition Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–21 year

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

comparative genomic hybridization

Genetic

gene expression analysis

Genetic

study of socioeconomic and demographic variables

Other

evaluation of cancer risk factors

Procedure

study of high risk factors

Procedure

Primary outcomes

  1. Presence of an oral human papillomavirus (HPV) type 16, 18, 6 or 11 infection

    Time frame: 2 years

  2. Presence of oral HPV infection by any of 37 HPV types

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 12, 2009
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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