Early detection of potentially malignant changes in oral leukoplakia using a saliva test

The most common oral precancerous lesions are leukoplakia and erythroplakia. Investigation on salivary biomarkers for oral cancer detection have been reviewed that patients with elevated SolCD44 and protein levels may be 25 times more likely to have oral cancer (Franzmann et al, 2019). CD44 is present in the basal and suprabasal epithelial layers in normal mucosa but expression extends to the superficial layers, which would have contact with the oral rinse, in severe dysplasia and cancer (Donovan et al, 2018). Lateral Flow device (OncAlert RAPID test) measures CD44 and total protein. The purpose of study was to detect the presence of SolCD44 and total protein CD44 in saliva of patients with oral leukoplakia. In the OncAlert Oral Cancer RAPID test validation studies were included 20 patients with oral leukoplakia, 5 patients with oral squamous cell cancer, 10 controls treated in the Department of Oral Pathology, RSU Library. The clinical forms of leukoplakia, expression intensity of Sol CD44 and total CD44 were evaluated independently by 3 clinicians. A positive test was accepted when SolCD44 test strip shows a positive result. Total protein CD44 was determined using color-graded scale (0-4). Results were evaluated by Excel program. The following forms of leukoplakia have been clinically identified: 18 non-homogeneous (4 verrucous, 9 erosive, 5 nodular) and 2 homogenous leukoplakia. Positive SolCD44 expression was found in all carcinoma patients as well as in patients with all forms of homogeneous and non-homogeneous leucoplakias. The total protein CD44 was estimated as high (3) both in homogenous and non- homogenous, but extreme high (4) only in non- homogenous leucoplakias. The expression of SolCD44 in control patients was 100% negative. The increased expression level of SolCD44 and of total protein CD44 possibly points to some malignant transformation changes in leukoplakia.