Saliva-based Detection of CD44

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.