Objective To evaluate septin-9 and clusterin protein levels in the peripheral blood samples from epithelial ovarian cancer patients, and explore its clinical significance. Methods Clinical data of 200 patients in Cancer Hospital,Chinese Academy of Medical Sciences from Jan. 29, 2008 to Feb. 1,2010 were collected. The peripheral blood samples were obtained from 137 epithelial ovarian cancer patients, 12 borderline ovarian tumor patients, 10 benign ovarian tumor patients, 41 benign pelvic lesion patients and 58 healthy women. The septin-9 and clusterin protein levels in the plasma were measured by double antibody sandwich ELISA or ELISA. The clinical significance of clusterin and septin-9 in plasma was analyzed. The diagnostic efficacy of septin-9 and clusterin protein in the detection of ovarian cancer was evaluated by the area under the curve (AUC) of the receiver operating characteristic (ROC) curve. Results Double antibody sandwich ELISA showed: the mean levels of plasma septin-9 in epithelial ovarian cancer patients or benign pelvic lesion patients were significantly higher than that in healthy women detedted by double antibody sandwich ELISA (P<0.01). The mean levels of plasma septin-9 in epithelial ovarian carcinoma patients with tumor family history or distance metastasis were significantly higher than those patients without (P<0.05). While the expression level of septin-9 protein in peripheral blood of ovarian cancer patients was not related to the patient age, pathologic stage, pathologic differentiation, smoking history, treatment history (including surgery, radiotherapy and chemotherapy) and lymph node metastasis (all P>0.05). ELISA showed: the mean level of plasma clusterin in epithelial ovarian cancer patients was significantly higher than that in healthy women deteded by ELISA (P=0.021). The expression level of clusterin protein in peripheral blood of ovarian cancer patients was not related to the above clinical pathological parameters (all P>0.05). To distinguish between ovarian cancer patients and healthy women by septin-9 protein expression level in plasma, when AUC was 0.712 and cut off was 0.28, the sensitivity of detection ovarian cancer by septin-9 protein expression was 82.5%, and the specificity was 50.0%. To distinguish between ovarian cancer patients and healthy women by clusterin protein expression level in plasma, when AUC was 0.636 and cut off was 87.96 pg/L, the sensitivity of detection ovarian cancer by clusterin protein expression was 71.5%, and the specificity was 41.4%. Conclusions The expression of septin-9 and clusterin protein in peripheral blood of ovarian cancer patients is increased, especially the expression level of septin-9 protein with related to the distant metastasis. The study results shown that the detection of septin-9 and clusterin in plasma has a certain diagnosis value in ovarian cancer, which may be a potential markers for ovarian cancer.%目的：检测卵巢上皮性癌（卵巢癌）患者外周血中septin-9、clusterin蛋白的表达，并探讨其临床意义。方法收集2008年1月29日至2010年2月1日间中国医学科学院北京协和医学院肿瘤医院收治的200例患者的临床病理资料，其中137例卵巢癌（卵巢癌组）、12例卵巢交界性上皮性肿瘤（交界性肿瘤组）、10例卵巢良性上皮性肿瘤（良性肿瘤组）、41例盆腔良性病变（盆腔良性病变组），以同期进行健康体检的58例健康妇女作为对照组，采用双抗体夹心法ELISA和ELISA法分别检测各组患者血浆中septin-9、clusterin蛋白的表达；分析血浆中septin-9、clusterin蛋白表达的临床意义；并以受试者工作特征（ROC）曲线的曲线下面积（AUC）评估血浆中septin-9、clusterin蛋白检测对卵巢癌的诊断效能。结果双抗体夹心法ELISA法检测显示，卵巢癌组和盆腔良性病变组患者外周血中septin-9蛋白表达水平（A值分别为0.35±0.09、0.36±0.09）明显高于对照组（A值为0.31±0.12，P<0.01）；而交界性肿瘤组、良性肿瘤组（A值分别为0.30±0.04、0.33±0.04）分别与对照组比较，差异则无统计学意义（P>0.05）。卵巢癌患者外周血中septin-9蛋白表达水平与有无肿瘤家族史（A值分别为0.38±0.10、0.34±0.08）和远处转移（A值分别为0.37±0.10、0.34±0.08）有关（P<0.05），而与年龄、手术病理分期、病理分化程度以及有无吸烟史、治疗史（包括手术、放化疗）和淋巴结转移均无关（P>0.05）。ELISA法检测显示，卵巢癌组患者外周血中clusterin蛋白表达水平明显高于对照组[分别为（109±52）、（103±18）pg/L，P=0.021]；而交界性肿瘤组、良性肿瘤组、盆腔良性病变组[分别为（88±41）、（91±23）、（94±29）pg/L]分别与对照组比较，差异则均无统计学意义（P>0.05）。卵巢癌患者外周血中clusterin蛋白表达水平与上述临床病理指标均无关（P>0.05）。以血浆中septin-9蛋白表达水平区分卵巢癌患者和健康体检妇女时，其AUC为0.712，当ROC曲线的界值定为0.28时，septin-9蛋白表达水平诊断卵巢癌的敏感度为82.5%，特异度为50.0%；以血浆中clusterin蛋白表达水平区分卵巢癌患者和健康体检妇女时，其AUC为0.636，当ROC曲线的界值定为87.96 pg/L时，clusterin蛋白表达水平诊断卵巢癌的敏感度为71.5%，特异度为41.4%。结论卵巢癌患者外周血中septin-9和clusterin蛋白高表达，且卵巢癌有远处转移患者外周血中septin-9蛋白表达更高；血浆中septin-9和clusterin蛋白检测对卵巢癌的诊断有一定的价值，表明septin-9和clusterin蛋白可能是潜在的卵巢癌患者的血浆标志物。
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