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

May 20, 2025 updated by: New Mexico Cancer Research Alliance

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.

Study Overview

Status

Completed

Conditions

Oropharyngeal Cancer

Detailed 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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Mexico
  - Albuquerque, New Mexico, United States, 87131-0001
    - University of New Mexico Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cultured Cell Exosome Protein Signature Outcome Measure Time Frame: 1 month	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exosome Signatures Oropharyngeal Rinse Measure Time Frame: 1 month	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Mexico Cancer Research Alliance

Investigators

Principal Investigator: Andrew Cowan, MD, University of New Mexico Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2015

Primary Completion (Actual)

May 8, 2024

Study Completion (Actual)

July 25, 2024

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria