Saliva-based Detection of CD44

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

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

Inclusion Criteria:

• Patient has the ability to understand and the willingness to sign a written informed consent.
• Previously untreated, measurable squamous cell carcinoma of the oral cavity or oropharynx with no evidence of distant metastasis, T1-4N0-3M0
• No prior history of treated upper aerodigestive tract cancer
• No concurrent, second, active malignancy other than oral cavity and/or oropharynx cancer
• Planned to undergo treatment with curative intent
• Able to follow up after therapy at 3, 6, 12, and 18 months after completion of therapy during routine post treatment follow up
• For control subjects: no evidence or history of upper aerodigestive tract cancer
• For control subjects: absence of any suspected or confirmed active malignancy at time of enrollment
• Patients may have had prior therapy for malignancy other than upper aerodigestive malignancy completed 2 years prior to enrollment if they have been disease free since completion of therapy
• Patient is ≥ 18 years of age.
• Both men and women of all races and ethnic groups are eligible for this trial.
• Performance Status ≤ ECOG 3
• Patient is able to gargle and spit 5 cc of saline
• Patients may be concurrently enrolled in other therapeutic or detection clinical trials

Exclusion Criteria:

• Prior completed therapy for an upper aerodigestive tract cancer within the past 3 years.
• Patient unable to gargle and spit 5 cc of saline, or anticipated to be unable to gargle and spit after completion of therapy
• Patient unable or does not intend to undergo curative therapy
• Patient with concurrent, second primary malignancy under active therapy or completed therapy within 2 years prior to enrollment.