Objective: To evaluate the soluble TIM-3 (sTIM-3) expression level in oral squamous cell carcinoma (OSCC) and determine its clinical diagnostic potential. Methods: The sTIM-3 and squamous cell carcinoma antigen (SCCAg) levels of 199 OSCC patients and 107 healthy individuals were assessed using an enzyme-linked immunosorbent assay and their individual and combined efficiency rates were compared. Results: The results showed higher sTIM-3 and SCCAg levels in the OSCC patients and better diagnostic potential for a combination of these markers than for their individual assessments, as well as positive correlation of sTIM-3 levels with clinicopathological factors. Conclusion: sTIM-3 is a potential novel and readily accessible OSCC biomarker, which in combination with SCCAg expression level might better diagnose OSCC patients.

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5023 Background: Studies show that ovarian cancer patients operated on by gyn oncologists are more often adequately staged and debulked than those operated on by non-gyn oncologists. Many benign gynecologic conditions will elevate the CA125 tumor marker decreasing its specificity. An accurate test is needed to help triage patients with a pelvic mass to centers with expertise in treating ovarian cancer. This project examined several novel tumor markers to develop a multiple biomarker assay to predict the risk of ovarian cancer in patients with an ovarian cyst or pelvic mass. Methods: Data from two separate IRB approved prospective trials from two institutions were collected. After obtaining informed consent, serum samples were obtained preoperatively from women undergoing surgery for an adnexal mass and analyzed for levels of CA125, SMRP, HE4 and CA72–4. All pathology results were compared to the tumor markers. Sensitivities at set specificities of 90, 95 and 98% were determined using logistic regression for each marker individually and all combinations of 2, 3, & 4 markers. Results: 448 samples were analyzed. There were 267 benign cases and 181 ovarian cancers (27 stage I, 20 stage II, 115 stage III and 19 stage IV). Median values for HE4, SMRP, CA125 and CA72–4 all differed significantly between benign masses and cancer (p < 0.001). In the differentiation of benign masses and stage I malignancies, the addition of HE4 to CA125 increased the sensitivity by 22.2% at a specificity of 90%. The combination of HE4 and CA125 for all stages was superior to HE4 or CA125 alone (p ≤ 0.003). Conclusions: The improvement in sensitivity shown by the addition of HE4 to CA125 suggests that this biomarker combination can be used to provide an accurate risk assessment for the presence of ovarian cancer in patients with an ovarian cyst or mass. This multiple biomarker assay is now undergoing validation in a multicenter prospective study. [Table: see text] [Table: see text]