Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Observational, Single-Institution Pilot/Feasibility Study of Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma

Conditions
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Oropharyngeal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Cancer Patients): Male or Female Age greater than or equal to 18 Previously untreated, pathologically confirmed OPSCC (HPV+ or HPV-) Ability to understand study information and provide written consent for participation. Inclusion Criteria (Non-cancer Patients): Male or Female Age greater than or equal to 18 Ability to understand study information and provide written consent for participation Exclusion Criteria: Age less than 18 years Prisoners Pregnant women Patients with mental disability

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: HPV-positive Cancer<br>Oropharyngeal cancer patients testing positive for human papillomavirus (HPV) | |
| Group 2: HPV-positive Cancer<br>Oropharyngeal cancer patients who test positive for human papillomavirus (HPV) | |
| Group 3: Healthy Controls<br>Patients with benign conditions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck cancer, Throat cancer, Human papillomavirus, HPV, Exosome, Diagnostic, Early Detection