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临床试验/NCT03337347
NCT03337347已完成不适用

Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients

The Institute of Molecular and Translational Medicine, Czech Republic1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2004年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
256
试验地点
1
主要终点
CEA mRNA positive circulating tumor cells in colorectal cancer patients

研究概览

简要总结

To determine whether the presence of circulating/disseminated tumor cells (CTCs/DTCs) in the blood and bone marrow of colorectal cancer (CRC) patients with localized disease is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •- colorectal adenocarcinoma

排除标准

  • •prior neoadjuvant chemoradiotherapy
  • •prior colorectal cancer
  • •cancer duplicity

结局指标

主要结局

CEA mRNA positive circulating tumor cells in colorectal cancer patients

时间窗: 1 day

The absolute gene expression of carcinoembryonic antigen (CEA mRNA) in circulating tumor cells (CTCs) purified from peripheral blood of patients before colorectal surgery will be measured using real-time RT-PCR method. The CEA gene expression will be normalized per microgram of total mRNA. The cut-off values identifying presence or absence of CEA mRNA positive CTCs in patients was established using the maxstat() function from the maxstat R package as a mode value of estimates obtained for 10 000 random samples. CEA mRNA levels above 190 CEA mRNA copies per microgram of RNA will indicate the presence of the CTCs in the peripheral blood sample.

次要结局

  • Cancer specific survival in CTC positive CRC patients(10 years)

研究者

发起方
The Institute of Molecular and Translational Medicine, Czech Republic
申办方类型
Other
责任方
Sponsor

研究点 (1)

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