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

NCT ID: NCT02147418

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-25
• Study Completion Date: 2024-07-25

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.

Conditions

Oropharyngeal Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1: HPV-positive Cancer

Oropharyngeal cancer patients testing positive for human papillomavirus (HPV)

No interventions assigned to this group

Group 2: HPV-positive Cancer

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

No interventions assigned to this group

Group 3: Healthy Controls

Patients with benign conditions

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New Mexico Cancer Research Alliance

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Cowan, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Cancer Center

Locations

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Countries

United States

Related Links

http://cancer.unm.edu

University of New Mexico Cancer Center

http://www.nmcca.org

New Mexico Cancer Care Alliance

Other Identifiers

INST 1310

Identifier Type: -

Identifier Source: org_study_id