跳至主要内容
临床试验/NCT03295591
NCT03295591Unknown不适用

Optimizing the Selection of Patients With Metastatic Colorectal Cancer for Liver Resection - An Immuno-clinical Scoring System Incorporating Circulating Tumor Cell Enumeration and Clinical Factors

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
77
试验地点
1
主要终点
Cutoff value of CTC counts

研究概览

简要总结

Resection of liver metastasis is potentially curative in patients with colorectal cancer bearing liver metastasis. However, early recurrence occurs in up to 30% in 3 months after liver resection. To optimize patient selection, the investigators propose to evaluate the the value of incorporating circulating tumor cells enumeration to clinical factors in a prospective study

详细描述

This is a single-center prospective study to evaluate the predictive value of circulating tumor cells (CTC) in patients with metastatic colorectal cancer who are planned to have curative resection of liver metastasis. Blood will be taken from patients within 7 days before liver resection. CTC enumeration is done by a highly-sensitive microfluidic platform for which CTC can be subsequently enumerated with or without sequencing performed. Patients are then followed up regularly with contrast CT scan for recurrence. The primary study endpoint is to define the cutoff value of CTC count in patients with early relapse < 6months after liver resection. Seventy-seven patients will be recruited in 24 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age>=18 years
  • Signed informed consent
  • Histologically or cytologically confirmed colorectal adenocarcinoma
  • Both primary tumor and liver metastases are amenable to curative resection.

排除标准

  • Presence of extrahepatic metastasis
  • History of other malignancies in the last 5 years
  • Patients unable to comply with the protocol

结局指标

主要结局

Cutoff value of CTC counts

时间窗: Progression free survival at 6 months

to identify patients with early relapse (\<6 months) after liver resection as determined by the AUC under the ROC curve

次要结局

  • Progression free survival(up to 5 years)
  • Overall survival(up to 5 years)
  • A immuno-clinical scoring system(Progression free survival at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Lam Ka On

Clinical Assistant Professor

The University of Hong Kong

研究点 (1)

Loading locations...

相似试验