Clinical trial NCT02147418: Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma
Official title: An Observational, Single-Institution Pilot/Feasibility Study of Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharyngeal Cancer
Keywords: Head and neck cancer
Throat cancer
Human papillomavirus
HPV
Exosome
Diagnostic
Early Detection
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cultured Cell Exosome Protein Signature Outcome Measure
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
measure: Exosome Signatures Oropharyngeal Rinse Measure
timeFrame: 1 month
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico Cancer Center
name: Andrew Cowan, MD
role: PRINCIPAL_INVESTIGATOR
References: