Oral HPV Infection in Young Men

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00897273

Enrollment

500

Registered

2009-05-12

Start date

2007-05-31

Completion date

2009-05-05

Last updated

2019-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Infection, Precancerous Condition

Keywords

recurrent squamous cell carcinoma of the oropharynx, oropharyngeal cancer, oropharyngeal squamous cell carcinoma, infection, precancerous condition, human papilloma virus infection

Brief 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.

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.

Interventions

GENETICcomparative genomic hybridization

GENETICgene expression analysis

OTHERstudy of socioeconomic and demographic variables

PROCEDUREevaluation of cancer risk factors

PROCEDUREstudy of high risk factors

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 21 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026