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.
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
Study Type
OBSERVATIONAL
Enrollment
85
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
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
To validate performance of the Vigilant Oral Rinse Point of Care strip in a multi-institutional clinical setting
* The agreement between CD44 ELISA and BCA test as measured using the POC test (OncAlert) and central laboratory testing at Vigilant The concordance of these two measures will be assessed using Cohen's kappa statistic for a dichotomized outcome (positive vs. negative test). A kappa of 0.6 or lower will be considered of insufficient concordance, and the minimum required level indicating adequate concordance is a kappa of 0.8 * The sensitivity and specificity of the OncAlert test to detect OOPSCC in cases compared to a non cancer control population. * A specificity of 0.65 minimally acceptable for the Vigilant POC test. In order to demonstrate a clinically acceptable level of specificity, a performance goal of 0.75 is chosen
Time frame: 4 years
To prospectively validate the performance of pretreatment Vigilant Oral Rinse Point of Care strip and Sol CD44 as a predictor of outcome for oral/oropharyngeal cancer in a point of care multi-institutional clinical setting
\- The association of salivary CD44 POC test biomarkers, including both the POC test and quantitative ELISA based assay with clinical characteristics of OOPSCC patients, such as site, stage, treatment, smoking, alcohol, HPV status, and patient overall and disease free survival using univariate and multivariate analyses.
Time frame: 4 years
To determine the association of post treatment salivary solCD44 and the Vigilant Oral Rinse Point of Care strip with disease outcome in oral/oropharyngeal cancer
\- The association of salivary CD44 POC test biomarkers, including both the POC test and quantitative ELISA based assay with recurrence of OSCC in an OSCC population with clinical characteristics of OOPSCC patients, such as site, stage, treatment, smoking, alcohol, HPV status, and patient overall and disease free survival using univariate and multivariate analyses and determine the magnitude of that association.
Time frame: 4 years
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