Oral HPV Infection in Young Men

NCT00897273 | Completed

• 5 other identifiers: J0729P30CA006973NA_00009472JHOC-J0729CDR0000554422
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

comparative genomic hybridization GENETIC

gene expression analysis GENETIC

study of socioeconomic and demographic variables OTHER

evaluation of cancer risk factors PROCEDURE

study of high risk factors PROCEDURE

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Related 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.

  PMID: 18809146 RESULT

Related Links

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

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.

MeSH Terms

Conditions

Head and Neck Neoplasms; Infections; Precancerous Conditions; Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms; Papillomavirus Infections

Interventions

Comparative Genomic Hybridization; Gene Expression Profiling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytogenetic Analysis; Genetic Techniques; Investigative Techniques; Molecular Diagnostic Techniques; Nucleic Acid Hybridization

Study Officials

• Maura Gillison, MD, PhD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: May 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 5, 2009
• Last Updated: January 17, 2019

Record last verified: 2013-04