CTC-Biopsy系统检测肿瘤患者外周血CTC临床应用可行性研究

Feasibility study of CTC-Biopsy detection system for detecting CTC in peripheral blood of patients with cancer

目的循环肿瘤细胞(circulating tumor cell,CTC)在判断临床分期、评估预后、监测疗效、辅助诊断和指导个体化治疗等方面表现出巨大潜力。本研究在完善和优化CTC-Biopsy检测系统的基础上,通过临床试验验证其检测肿瘤患者外周血中CTC的效果,探讨其临床推广应用的价值。方法使用CTC-Biopsy检测系统,按照中国国家食品药品监督局(China Food and Drug Administration,CFDA)的药物临床试验管理规范(Good Clinical Practice,GCP),对山东大学附属山东省肿瘤医院2014-09-01-2014-12-31收治的150例肿瘤患者及2014-12-12-2014-12-15 22名健康志愿者进行了临床试验。结果 CTC-Biopsy检测系统检测的染色标本背景干净,细胞形态清晰,细胞核质分界清楚;除异常细胞外,样片中仅残留少量的单核细胞。CTC-Biopsy检测系统检测不分病种恶性肿瘤灵敏度为51.33%(77/150),特异性为100.00%(77/77),约登指数为0.513。由CTC-Biopsy检测系统的CTC检出率的95%CI下限为43.33%,大于国际ISET法报道的43.06%。胃癌Ⅳ期患者检出率高于Ⅰ～Ⅲ期患者,差异有统计学意义,P=0.002。结论通过GCP临床试验证实,CTC-Biopsy系统检测肿瘤患者外周血中CTC的灵敏度、特异性等指标均达到国际同类检测系统水平。该系统检测操作简便易行,且高效、稳定和经济,具有良好的临床推广价值。

OBJECTIVE Circulating tumor cells(CTC)have great potential in judging the clinical stage of tumors,evaluating tumor prognosis,monitoring efficacy,assisting diagnosis and guiding individualized treatment.The purpose of this experiment was to improve and optimize the CTC-Biopsy detection system,verify the effect of CTC in the peripheral blood of tumor patients,and explore the value of clinical application.METHODS Using the CTC-Biopsy test system,according to China’s State Food and Drug Administration(CFDA)clinical trial management specification(GCP,good clinical practice)requirements,150 patients with cancer and 22 healthy volunteers admitted to Shandong Cancer Hospital underwent clinical trials.RESULTS CTC-Biopsy detection system test specimens were stained with clean background,clear cell morphology,cell nucleus and cytoplasm clear boundaries;except for abnormal cells,sample only residual small amounts of mononuclear cells.CTC-Biopsy detection system detection sensitivity of disease of malignant diseases:51.33%(77/150),specificity:100.00%(77/77),Youden index:0.513.The 95%CI detection rate of CTC detection system was 43.33%,which was higher than that of the ISET 43.06%.In patients with stage IV gastric cancer detection rate was significantly higher than that of the patients withⅠ-Ⅲstage(P=0.002).CONCLUSIONS The GCP clinic trail confirmed CTC-Biopsy detection system for detecting cancer patients peripheral blood in CTC sensitivity,specificity and other indicators have reached the international similar detection system level.The detection system is easy to operate and convenient,with efficient,stable and economical advantages,with good clinical value.