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

Last updated: May 20, 2025
Sponsor: New Mexico Cancer Research Alliance
Overall Status: Completed

Phase

N/A

Condition

Oral Cavity Cancer

Lung Cancer

Oral Cancer

Treatment

N/A

Clinical Study ID

NCT02147418
INST 1310
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 forparticipation.

Inclusion Criteria (Non-cancer Patients):

  • Male or Female

  • Age greater than or equal to 18

  • Ability to understand study information and provide written consent forparticipation

Exclusion

Exclusion Criteria:

  • Age less than 18 years

  • Prisoners

  • Pregnant women

  • Patients with mental disability

Study Design

Total Participants: 15
Study Start date:
February 25, 2015
Estimated Completion Date:
July 25, 2024

Study 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.

Connect with a study center

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87131-0001
    United States

    Site Not Available

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