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Clinical Validation of Salivary Oral Cancer Biomarkers

Institution: University of California, Los Angeles
Investigator(s): David Wong, DMD, DMSc
Award Cycle: 2012 (Cycle 21) Grant #: 21RT-0112 Award: $521,831
Subject Area: Early Diagnosis/Pathogenesis
Award Type: Research Project Awards

Initial Award Abstract

Oral cancer is a tobacco-related disease where annually there are 38,000 new cases in the US and 400,000 new cases globally. One patient dies from oral cancer every hour in the U.S. In some parts of the world, including the Indian subcontinent, oral cancer is a major cancer problem. Chronic exposure to tobacco products is the classic and most common etiological factor for OSCC, responsible for 95% of oral cancer. Most oral cancers are diagnosed at late stages and the five year survival rate of oral cancer has not changes in the last three decades, highlighting the urgent need for the development of effective early screening technologies to identified patients with oral cancer.

The applicant’s laboratory at UCLA is the leading laboratory in the development of basic and translational sciences for salivary diagnostics, including five diagnostic alphabets (proteome, transcriptome, micro-RNA, metabolome and microbiome). We have also developed point-of-care biosensor technologies that can detect salivary biomarkers with exquisite sensitive in a multiplexible, real time and automated platform.

Using these optimized saliva diagnostic tools, we have development highly discriminatory salivary proteomic and transcriptomic biomarkers for oral cancer detection. A combination of five proteomic candidate biomarkers yielded a ROC value of 93%, sensitivity of 90%, and specificity of 83% in detecting OSCC whereas a combination of the salivary transcriptome biomarkers yielded sensitivity (91%) and specificity (91%) in distinguishing oral cancer from the controls. This TRDPR Research Project Award application is to test the hypothesize that the discovered and pre-validated salivary biomarker can be independently validated in prospective study in a relevant clinical setting to assess if a persistent suspicious oral lesion is cancer or not. This three-year application is to advance the pre-validated salivary oral cancer biomarkers to a clinical panel that can be definitively evaluated in a multi-center clinical validation study permitting the subsequent next steps of regulatory approval and product development.

Two specific aims are in place to test the central hypothesis. Aim 1 is to enroll 1260 subjects with persistent suspicious oral lesion from the Oral Mucosal Clinics at UCLA and NYU during the first two years. Aim 2 is to perform individual biomarker validation in an independent cohort of persistent suspicious oral mucosal lesions; developed a panel of highly discriminatory biomarkers for oral cancer detection and then validate the panel in an independent cohort of persistent suspicious oral lesions.