Friedrich M G, Toma M I, Hellstern A, Pantel K, Weisenberger D J, Noldus J, Huland H
Department of Urology, University Hospital Hamburg-Eppendorf, University of Hamburg, Germany.
BJU Int. 2003 Dec;92(9):911-4. doi: 10.1111/j.1464-410x.2003.04528.x.
To present a single-centre study investigating aneuploidy at chromosomes 3, 7, 17 and 9p21 (e.g. loss at 9p21) using a multitarget fluorescence in situ hybridization (FISH) system, as identifying genetic alterations in urine specimens is a promising approach for the noninvasive detection of bladder cancer.
Urine samples from 103 patients were evaluated, including those from 46 with histologically confirmed urothelial carcinoma, two with other urological malignancies, and 55 who acted as controls. The urine samples were taken before any manipulation. The validity of FISH (Urovision, Vysis, Downers Grove, Ill, USA) was compared with other noninvasive urine tests, including the BTA-Stat test, the nuclear matrix protein (NMP)-22 test, and immunocytology against 486p3/12 and LewisX. Those evaluating the tests were unaware of the clinical and histopathological data. FISH was considered positive if five or more urinary cells had gains of two or more chromosomes. The threshold for the urine tests were 10 U/mL (NMP-22), 30% positive cells (486p3/12), or 5% positive cells, respectively (LewisX).
The sensitivity was 69% (FISH), 67% (BTA-Stat), 69% (486p3/12), 96% (LewisX) and 71% (NMP22), respectively; the respective specificity was 89%, 78%, 76%, 33% and 66%.
Multitarget FISH had a better specificity than the other urine markers but because of its inadequate sensitivity it does not seem to be powerful enough to replace endoscopy. Optimizing the marker panel could provide a higher sensitivity.
开展一项单中心研究，使用多靶点荧光原位杂交（FISH）系统检测3号、7号、17号染色体及9p21（如9p21缺失）的非整倍体情况，因为识别尿液标本中的基因改变是一种很有前景的膀胱癌无创检测方法。
对103例患者的尿液样本进行评估，其中包括46例经组织学确诊的尿路上皮癌患者、2例患有其他泌尿系统恶性肿瘤的患者以及55例作为对照的患者。尿液样本在进行任何操作之前采集。将FISH（Urovision，Vysis，美国伊利诺伊州唐纳斯格罗夫）的有效性与其他无创尿液检测方法进行比较，包括BTA-Stat检测、核基质蛋白（NMP）-22检测以及针对486p3/12和LewisX的免疫细胞检测。进行检测评估的人员不知道临床和组织病理学数据。如果五个或更多尿细胞出现两条或更多染色体的增加，则FISH被视为阳性。尿液检测的阈值分别为10 U/mL（NMP-22）、30%阳性细胞（486p3/12）或5%阳性细胞（LewisX）。
敏感性分别为69%（FISH）、67%（BTA-Stat）、69%（486p3/12）、96%（LewisX）和71%（NMP22）；各自的特异性分别为89%、78%、76%、33%和66%。
多靶点FISH比其他尿液标志物具有更好的特异性，但由于其敏感性不足，似乎不足以强大到取代内镜检查。优化标志物组合可能会提供更高的敏感性。
