Oral HPV Infection in Young Men

Johns Hopkins Medicine

Status: Completed

Conditions: Infection; Precancerous Condition; Head and Neck Cancer

Treatments: Genetic: comparative genomic hybridization; Procedure: evaluation of cancer risk factors; Other: study of socioeconomic and demographic variables; Genetic: gene expression analysis; Procedure: study of high risk factors

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00897273

J0729

P30CA006973 (U.S. NIH Grant/Contract)

JHOC-J0729

CDR0000554422 (Other Identifier)

NA_00009472 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: Male

Ages: 18 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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