Characterization of salivary CD44 and total protein levels in patients with oral cavity dysplasia.

Abstract

e18120 Background: Previous studies have identified altered salivary CD44 and total protein (TP) levels in patients with oral cavity cancer (OCC), suggesting potential as diagnostic biomarkers. However, their role in earlier stages of disease, such as dysplasia, remains poorly characterized. This study aims to compare salivary biomarker levels in patients with oral cavity dysplasia, patients with OCC, and controls. Methods: This study compared CD44 and TP in patients with newly diagnosed, biopsy-proven oral cavity dysplasia or OCC at an academic medical center between 2023-2024, as well as with healthy controls. Patients were consented to an oral rinse OCC early detection study, a chemopreventive drug trial for patients with oral dysplasia, or a community screening study in an underserved community. All patients provided oral rinses and consented to future study of their lab data. Control patients had no concerning head and neck physical examination findings, and we excluded controls with a history of head and neck cancer. ELISA and modified Lowry protein assays were performed to determine biomarker levels. Individual samples T-tests were used to compare mean biomarker levels between dysplasia patients versus controls and versus OCC patients. LN transformed data was used for statistical analysis due to non-normality of biomarker values. SPSS v29.0 was used for analysis. Results: 80 patients (10 with dysplasia, 26 with OCC, and 44 controls) were included in our analysis. The mean cohort age was 59.39 (SD= 14.84) years, 59 (73.8%) were white, and 33 (41.3%) were male. Biopsy revealed 7 dysplasia patients with at least “high-grade” or “severe” dysplasia and 3 dysplasia patients with “mild to moderate” or “low-grade” dysplasia. 7 of 10 OCD patients and 5 of 26 OCC patients had a prior history of head and neck cancer. Overall, dysplasia patients exhibited higher TP (mean 0.82 mg/mL, SD = 0.58) and CD44 levels (mean 12.83 ng/mL , SD = 8.54) compared to controls (TP mean 0.41 mg/mL, SD = 0.212; CD44 mean 5.29 ng/mL, SD =3.66) (p<0.05 for TP; p<0.001 for CD44). OCC patients also had higher TP levels (mean 0.67 mg/mL, SD = 0.36) than controls (mean 0.41 mg/mL, SD = 0.212) and higher CD44 levels (mean 9.92 ng/mL, SD = 6.725) than controls (mean 5.20 ng/mL, SD = 6.725) (p<0.001 for both). There were no differences in TP(LN) and CD44(LN) levels between dysplasia and OCC patients. Conclusions: This study provides preliminary insights into salivary CD44 and total protein levels in patients with oral cavity dysplasia. By characterizing these biomarkers in an at-risk cohort, our findings support the potential of CD44 and TP as biomarkers for the detection of dysplasia in addition to OCC underscoring their potential to diagnose disease before it becomes invasive. Early detection may ultimately improve early intervention and reduce the burden of oral cancers. Further study with a larger number of subjects is needed to confirm these results.