Oral HPV Infection in Young Men

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897273
• Other study ID #: J0729
• Secondary ID: P30CA006973NA_00
• Status: Completed
• Start date: May 2007
• Est. completion date: May 5, 2009

Study information

• Verified date: April 2013
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 5, 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Head and Neck Cancer
• Head and Neck Neoplasms
• Infection
• Oropharyngeal Neoplasms
• Papillomavirus Infections
• Precancerous Condition
• Precancerous Conditions

Intervention

Genetic:
• comparative genomic hybridization

• gene expression analysis

Other:
• study of socioeconomic and demographic variables

Procedure:
• evaluation of cancer risk factors

• study of high risk factors

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

References & Publications (1)

Gillison ML. Human papillomavirus-related diseases: oropharynx cancers and potential implications for adolescent HPV vaccination. J Adolesc Health. 2008 Oct;43(4 Suppl):S52-60. doi: 10.1016/j.jadohealth.2008.07.002. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of an oral human papillomavirus (HPV) type 16, 18, 6 or 11 infection		2 years
Primary	Presence of oral HPV infection by any of 37 HPV types		2 years

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database