Oral HPV Infection in Young Men

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Completed
• CT.gov ID: NCT00897273
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 500
• Duration (Months): 24.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Human Papillomavirus Infection of the Mouth in Young Men and Risk Factors for Oropharyngeal Cancer
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 5, 2009

Outcome Measures

Primary Outcome Measures

1. Presence of an oral human papillomavirus (HPV) type 16, 18, 6 or 11 infection [2 years]

2. Presence of oral HPV infection by any of 37 HPV types [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 21 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• National Cancer Institute (NCI)

Investigators

• Study Chair: Maura Gillison, MD, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT00897273
• Other Study ID Numbers: J0729; P30CA006973; NA_00009472; JHOC-J0729; CDR0000554422
• First Posted: May 12, 2009
• Last Update Posted: Jan 17, 2019
• Last Verified: Apr 1, 2013

• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: recurrent squamous cell carcinoma of the oropharynx; oropharyngeal cancer; oropharyngeal squamous cell carcinoma; infection; precancerous condition; human papilloma virus infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Precancerous Conditions

Study Results

No Results Posted as of Jan 17, 2019