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

Oropharyngeal Cancer Clinical Trial

Official title:

An Observational, Single-Institution Pilot/Feasibility Study of Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02147418
• Other study ID #: INST 1310
• Status: Recruiting
• Start date: February 25, 2015
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: New Mexico Cancer Care Alliance
• Contact: Andrew Cowan, MD
• Email: AnCowan[@]salud.unm.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exosome Signatures Oropharyngeal Rinse Measure	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
Primary	Cultured Cell Exosome Protein Signature Outcome Measure	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

External Links

•   New Mexico Cancer Care Alliance
•   University of New Mexico Cancer Center