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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| NA_00009472 | Other Identifier | JHM IRB | |
| JHOC-J0729 | |||
| CDR0000554422 | Other Identifier | other |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | 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 |
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DISEASE CHARACTERISTICS:
Currently enrolled at one of the following institutions:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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A convenience sample of 500 men recruited from Baltimore-area college health centers (Johns Hopkins University, University of Maryland, or Towson University).
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| Name | Affiliation | Role |
|---|---|---|
| Maura Gillison, MD, PhD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18809146 | Result | 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. |
| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D007239 | Infections |
| D011230 | Precancerous Conditions |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009959 | Oropharyngeal Neoplasms |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
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| ID | Term |
|---|---|
| D055028 | Comparative Genomic Hybridization |
| D020869 | Gene Expression Profiling |
| ID | Term |
|---|---|
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D025202 | Molecular Diagnostic Techniques |
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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.
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009693 | Nucleic Acid Hybridization |