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

Recruiting

• Conditions: Oropharyngeal Cancer

• Registration Number: NCT02147418
• Lead Sponsor: New Mexico Cancer Care Alliance

Brief 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.

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 Timeline

• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-26
• Study Start: 2015-02-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

• Age less than 18 years
• Prisoners
• Pregnant women
• Patients with mental disability

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cultured Cell Exosome Protein Signature Outcome Measure	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.

Trial Locations

Locations (1)

University of New Mexico Cancer Center; 🇺🇸 Albuquerque, New Mexico, United States