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能准确检测膀胱癌复发的尿检

By LabMedica International staff writers
Posted on 27 Aug 2018
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图片:Bladder EpiCheck诊断试剂盒(图片蒙Nucleix公司惠赐)。
图片:Bladder EpiCheck诊断试剂盒(图片蒙Nucleix公司惠赐)。

科研人员一直在研究通过尿检检测膀胱癌;然而,大多数尿检方法因为成本问题、现实问题或者灵敏度或特异性不如金标准而未付诸临床实践。

 

膀胱癌是欧盟诊断出的第五多的癌症,其复发率高达70%左右,需要频繁随访。标准随访程序包括细胞镜检,且与尿液分析配套使用,检查癌变的细胞,如果需要,再对疑似区域进行活组织检查。

 

荷兰奈梅亨拉德堡德大学医学中心(www.ru.nl)的科学家及其欧洲同行在欧洲的五所顶级泌尿中心开展了一项前瞻性单臂双盲临床研究,招募了440名处于随访期第一年的患者。记下细胞镜检和细胞化验的结果,如果检测到病灶,则记录组织学确认检查的日期与结果。

 

科研小组收集了一份尿样做Bladder EpiCheck检验,这款尿检是以色列雷霍沃特市Nucleix公司(https://nucleix.com)的产品,用途是根据15DNA甲基化生物标志物监测膀胱癌复发。中央实验室用该产品检验处理后五天以内且大于等于10毫升的尿液。处理环节包括离心,以分离细胞团,从中提取DNA。用甲基化敏感的限制酶在未甲基化的识别序列处切割DNA,同时保持甲基化序列不变,从而消化提取出的DNA。然后用针对位点的引物和探针(每份样本八个孔)进行实时聚合酶链反应,扩增消化后的DNA,用Bladder EpiCheck软件分析所得到的数据。

 

招募的440名患者中,353人符合性能分析的条件。总体灵敏度、特异性、阴性预测值(NPV)和阳性预测值分别为68.2%88.0%95.1%44.8%。如果排除轻度Ta复发,则灵敏度为91.7%NPV99.3%。有和没有轻度Ta病灶两种情况下,接受者操作特征(ROC)曲线下的面积分别为0.820.94403名有Bladder EpiCheck结果的病人中,320份样本(81.1%)为阴性,83份样本(18.9%)为阳性;平均EpiScore31.2 ± 26.6

 

Nucleix有限公司CEO Opher Shapira说:膀胱癌的问题不在于早期检测,因为它一般有血尿这样的信号。主要问题是监测癌症的复发,因为它是一种频繁复发的疾病。标准监测程序一再引起患者不适,并造成卫生系统的成本高昂。检验结果意味着如果医师让患者做我们的尿检并从化验室得到无癌症结果,就能确信他们的病人没有重度肿瘤。该研究的论文发表于2018715日的《欧洲泌尿肿瘤学》(European Urology Oncology)杂志。

Related Links:

奈梅亨拉德堡德大学医学中心>>> www.ru.nl

Nucleix >>> https://nucleix.com


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