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Brief Title: Saliva-based Detection of CD44
Official Title: A Prospective, Multi-site Trial of a Point of Care Saliva Based Detection Test Based on Soluble CD44 (OncAlert) for Presence of Disease in Previously Untreated Oral Cavity and Oropharynx Squamous Cell Carcinoma
Study ID: NCT03148665
Brief Summary: The purpose of this study is to test the ability of OncAlert™ to screen for cancer and the reappearance of cancer. OncAlert™ was developed by Vigilant Biosciences, a collaborator in this research study. OncAlert™ is an oral rinse which is spit into a cup and sent to a laboratory for analysis. OncAlert™ is considered experimental by the FDA because it is not approved for the screening of cancer.
Detailed Description: A noninvasive point of care salivary rinse test performed as 1) a one-time test for control subjects, 2) at pretreatment and post treatment 3,6, 12, and 18 month time points in oral cavity/oropharynx cancer patients
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
UCSD Moores Cancer Center, La Jolla, California, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Johns Hopkins School of Medicine, Baltimore, Maryland, United States
New York University College of Dentistry, New York, New York, United States
Name: Joseph Califano, MD
Affiliation: University of California, San Diego
Role: STUDY_CHAIR