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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:February 2015
End Date:December 2020
Contact:Andrew Cowan, MD
Email:AnCowan@salud.unm.edu

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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

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.

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
We found this trial at
1
site
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Andrew Cowan, MD
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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