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Cancer of the oropharynx (middle, side and back walls of the throat; back of the tongue; soft palate, and tonsils), or oropharyngeal squamous cell carcinoma (OPSCC), has been on the rise in the United States. Human papillomavirus (HPV) has been recognized in many of these cancers, and testing for HPV has contributed to the higher reported rates of OPSCC. In this study, our goal is to develop a new test that can detect certain HPV proteins in the blood or saliva to help improve detection of OPSCC.
While secondary screening strategies have successfully reduced the rate of HPV-positive cervical cancers, an effective screening modality for HPV-OPSCC does not exist. A central problem in the early diagnosis of HPV-OPSCC is the relative inaccessibility of the tonsillar crypts, where oncogenic infections are thought to originate. Unlike the relatively smooth surface of the cervix which permits mechanical sampling with Pap tests and which can be evaluated visually for evidence of dysplasia, much of the tonsillar epithelium is found below the surface in a complex network. As a consequence, any screening modality cannot depend upon direct access to malignant lesions. What is needed is a minimally invasive, diffusible or circulating marker of HPV-OPSCC, and a means to collect and detect it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: HPV-positive Cancer | Oropharyngeal cancer patients testing positive for human papillomavirus (HPV) | ||
| Group 2: HPV-positive Cancer | Oropharyngeal cancer patients who test positive for human papillomavirus (HPV) | ||
| Group 3: Healthy Controls | Patients with benign conditions |
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| Measure | Description | Time Frame |
|---|---|---|
| Cultured Cell Exosome Protein Signature Outcome Measure | The presence of unique proteins obtained from primary cell cultures derived from HPV-OPSCC confirmed patients will be compared to normal tonsillar epithelial cells and established cell lines. The distribution of these protein signatures will be compared in HPV-OPSCC and normal epithelial cells. | 1 month |
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| Measure | Description | Time Frame |
|---|---|---|
| Exosome Signatures Oropharyngeal Rinse Measure | Compare exosome protein signatures generated from cells obtained through oropharyngeal rinses of patients with HPV-positive OPSCC and normal controls to identify an exosome protein marker that is absent (or present at a different, statistically significant level) in the oropharyngeal rinses of normal controls. | 1 month |
Inclusion Criteria (Cancer Patients):
Inclusion Criteria (Non-cancer Patients):
Exclusion Criteria:
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The patient population will consist of adults presenting to the Division of Otolaryngology - Head and Neck Surgery at the University of New Mexico with previously untreated OPSCC. Both HPV-positive and HPV-negative malignancies will be collected as the study and control groups, respectively. In addition, saliva samples will be collected from patients presenting with benign conditions as a further negative control.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Cowan, MD | University of New Mexico Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-0001 | United States |
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| Label | URL |
|---|---|
| University of New Mexico Cancer Center | View source |
| New Mexico Cancer Care Alliance | View source |
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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All oropharyngeal rinse (gargle) specimens will be processed within 24 hours of collection. Any remaining material after testing will be stored for a period not to exceed 1 year in a secure location.
| D010608 |
| Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |