Simple SummaryOne way to facilitate the detection of early malignant transformation processes in oral potentially malignant disorders, including oral leukoplakia, involves the parallel evaluation of tissue and saliva biomarkers, as such indicators may elucidate both protein CD44 expression in leukoplakia tissue and its soluble form and total protein detection in saliva. We concluded that the OncAlert® Oral Cancer Rapid test is a non-invasive and simple but only screening method which can complement clinical diagnostics methods in daily clinical practice when considering oral leukoplakia, most importantly, in order to obtain information about the potential for early malignancy.The aim of this study was to determine whether and how pan-CD44 protein expression in leukoplakia tissues correlates with positive SolCD44 test presence and their role in oral leukoplakia. SolCD44 and total protein expression in saliva were determined using an OncAlert® Oral Cancer Rapid test. Comparison of paired associations of total protein, SolCD44, mean number of CD44 expressed epithelial layers in leukoplakia tissue, and macrophages below the basement membrane between control group and patients with leukoplakia showed statistically significant results (p < 0.0001). It is shown that the total protein indicates low or elevated risk of possible malignant transformation processes in leukoplakia. Statistically significant differences between higher total protein level and clinical forms of oral leukoplakia (p < 0.0001), as well as CD44-labeled epithelial cell layer decrease (p < 0.0001), were found. This possibly points to the onset of the stemness loss in leukoplakia tissue. CD9 antigen expression in the exosomes of the oral epithelium explained the intercellular flow of SolCD44 and other fluids in the leukoplakia area. We conclude that the OncAlert® Oral Cancer Rapid test is a valuable screening method in daily clinical practice, in terms of complementing clinical diagnostics methods and to assess the potential for early malignancy.
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