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

New Mexico Cancer Research Alliance

Status: Completed

Conditions: Oropharyngeal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02147418

INST 1310

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

15 participants in 3 patient groups

Group 1: HPV-positive Cancer

Description:

Oropharyngeal cancer patients testing positive for human papillomavirus (HPV)

Group 2: HPV-positive Cancer

Description:

Oropharyngeal cancer patients who test positive for human papillomavirus (HPV)

Group 3: Healthy Controls

Description:

Patients with benign conditions