Human Papillomavirus Infection of the Mouth in Young Men and Risk Factors for Oropharyngeal Cancer
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Oral HPV Infection in Young Men |
- Presence of an oral human papillomavirus (HPV) type 16, 18, 6 or 11 infection [ Designated as safety issue: No ]
- Presence of oral HPV infection by any of 37 HPV types [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Laboratory Methods:
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.
Serum sample:
Standard laboratory assays will be used to detect antibodies to HPV16 L1 viral capsid protein.
| Estimated Enrollment: | 500 |
| Study Start Date: | May 2007 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 21 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
A convenience sample of 500 men recruited from Baltimore-area college health centers (Johns Hopkins University, University of Maryland, or Towson University).
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 More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00897273 History of Changes |
| Other Study ID Numbers: | JHOC-J0729, CDR0000554422, P30CA006973, JHOC-J0729, JHOC-_NA_00009472 |
| Study First Received: | May 9, 2009 |
| Last Updated: | September 15, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
recurrent squamous cell carcinoma of the oropharynx oropharyngeal cancer oropharyngeal squamous cell carcinoma |
infection precancerous condition human papilloma virus infection |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Precancerous Conditions Oropharyngeal Neoplasms Warts Papillomavirus Infections Neoplasms by Site Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms |
Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases DNA Virus Infections Virus Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013