The GILUPI CellCollector (CC) is a novel in vivo circulating tumor cell (CTC) detection device reported to overcome the limitations of small blood sample volumes. The aim of this prospective, blinded study was to evaluate the clinical application of the CC and to compare its performance to the CellSearch (CS) system in M0 and M1 colorectal cancer (CRC) patients. A total of 80 patients (31 M0, 49 M1) with CRC were enrolled. CTCs were simultaneously measured in the peripheral blood using CS and the CC, and the results of both assays were correlated to clinicopathological variables and overall survival. The total number of detected CTCs and CTC-positive patients did not significantly differ between both assays. In the M0 patients, the CC detected CTCs more frequently than CS. There was no significant difference in total CTC numbers detected with the CC between M0 and M1 patients. In addition, no significant correlation with clinicopathological parameters or overall survival was observed with CC CTCs. In contrast, detection of CTCs with CS was significantly correlated with Union for International Cancer Control stage and reduced overall survival. There was no correlation between CTCs detected by the CC and the CS system. Using in silico analysis, we estimate that CC screens a volume of 0.33-18 mL during in vivo application, in contrast to much higher volumes reported elsewhere. In conclusion, while being safe and easy to use, the CC did not outperform CS in terms of CTC yield or sensitivity. While CTC detection in M0 CRC patients was significantly increased with the CC, the clinical relevance of these CTCs appears inferior to the cells identified by the CS system.

中文翻译：

---

使用GILUPI CellCollector检测大肠癌患者中循环肿瘤细胞：一项前瞻性，单中心研究的结果。

GILUPI CellCollector（CC）是一种新颖的体内循环肿瘤细胞（CTC）检测设备，据报道可克服小血样量的限制。这项前瞻性，盲目的研究的目的是评估CC在M0和M1大肠癌（CRC）患者中的临床应用，并与CellSearch（CS）系统进行比较。总共招募了80例CRC患者（31 M0、49 M1）。使用CS和CC同时测量外周血中的CTC，并且两种测定的结果都与临床病理变量和总体生存率相关。两种测定之间检测到的CTC和CTC阳性患者的总数没有显着差异。在M0患者中，CC比CS更频繁地检测到CTC。在M0和M1患者之间，通过CC检测到的总CTC数量没有显着差异。此外，CC CTCs与临床病理参数或总生存率无显着相关性。相反，使用CS检测CTC与联合治疗国际癌症控制分期显着相关，并降低了总生存率。CC和CS系统检测到的CTC之间没有相关性。使用计算机分析，我们估计在体内应用过程中CC筛选的体积为0.33-18 mL，而其他地方报道的体积要大得多。总而言之，尽管CC安全且易于使用，但在CTC产量或灵敏度方面都没有优于CS。CC使M0 CRC患者的CTC检测显着增加，