Human Papillomavirus Infection of the Mouth in Young Men and Risk Factors for Oropharyngeal Cancer
|ClinicalTrials.gov Identifier: NCT00897273|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : September 16, 2010
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|
|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|
- 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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Oral HPV Infection in Young Men|
|Study Start Date :||May 2007|
|Primary Completion Date :||May 2009|
- Presence of an oral human papillomavirus (HPV) type 16, 18, 6 or 11 infection
- Presence of oral HPV infection by any of 37 HPV types
Biospecimen Retention: Samples With DNA
Oral rinse sample:
Standard, well-validated assays will be used to detect HPV genomic DNA in oral exfoliated cells from the Scope oral rinse sample.
Standard laboratory assays will be used to detect antibodies to HPV16 L1 viral capsid protein.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897273
|Study Chair:||Maura Gillison, MD, PhD||Sidney Kimmel Comprehensive Cancer Center|