Developing an In-vitro Diagnostic Risk-Stratification Test for Oral Cancer

Saliva samples are collected from patients before clinically driven oral biopsy for lesions
suspicious for cancer. Specimens are processed by laboratory personnel blinded to the tissue
diagnosis. Six pre-specified mRNA markers (IL1b, IL8, SAT, DUSP1, OAZ1 and S100P) are
measured by polymerase chain reaction. Markers are compared in cancer and control by raw Ct
values as well as by delta Ct after adjustment for housekeeping gens. Appropriate
housekeeping genes are identified in a random subset of cancer and control patients and then
verified in the remaining subjects. Predictive models are generated by a pre-specified method
and robustness evaluated by bootstrap analysis. The model is then further validated in a
second cohort. Three pre-specified protein markers (IL8, IL1B, and M2BP) are a secondary
endpoint and will also be compared in cancer and control patients.

Inclusion Criteria:

- Adult patients scheduled for biopsy of an oral lesion suspicious for squamous cell
cancer

Exclusion Criteria:

- Patients with known prior oral malignancy in last 2 years or other cancer in last 5
years other than non melanoma skin cancer or with immune deficiency