High soluble CD44 and total protein levels in oral rinses are strongly associated with head and neck squamous cell carcinoma

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Introduction: Head and neck squamous cell carcinoma (HNSCC) is a devastating disease that is cured only 50% of the time largely due to late stage diagnosis. Because there is no established screening program for this disease, we aim to identify simple, noninvasive molecular-based tools that detect HNSCC at an early, treatable stage. Our previous work shows that soluble CD44 (solCD44) levels and total protein levels are elevated in HNSCC patients compared to controls. Here we examine whether the combination of these two tests holds promise for early detection of HNSCC.
 >Methods: We performed the solCD44 ELISA (Bender MedSystems, Vienna, Austria) and total protein (Bio-Rad, Hercules, California) assays following the manufacturers recommendations with our modifications on oral rinse samples from 102 HNSCC cancer patients and 84 controls. Controls included 69 subjects with benign disease and 15 disease-free volunteers.
 >Results: High levels of both solCD44 and total protein are significantly associated (OR= 24.8, 95% CI = 8.6, 71.4) with HNSCC suggesting that these markers may be useful in combination. Similar to solCD44 levels, total protein levels vary with tumor site but not tumor size, stage or history of prior treatment. Tobacco use history was available for 42 HNSCC patients and 71 controls. For both solCD44 and total protein, HNSCC smokers did not differ from HNSCC nonsmokers and control smokers did not differ from control nonsmokers.
 >Conclusions: The combination of solCD44 and total protein levels may be useful for early detection of HNSCC. History of tobacco use does not appear to significantly impact results indicating that these tests may suitable for high-risk populations.