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临床试验/NCT05420415
NCT05420415已完成不适用

The Tumor Microenvironment Collagen Signature (CSTME) Associates With the Prognosis of Stage II and III Colorectal Cancer : A Multi-Center Retrospective Observational Cohort Study

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
570
试验地点
1
主要终点
5-year DFS

研究概览

简要总结

Colorectal cancer (CRC) is the second most commonly occurring cancer worldwide. Thirty-five percent of CRC patients are diagnosed at stage II/III, and their outcome differs even if they are in the same stage. Previous study found that the microenvironmental collagen is associated with tumor progression and metastasis. Whether tumor microenvironmental collagen signature is associated with colorectal cancer prognosis still remains unknown. We hypothesize that the tumor microenvironmental collagen signature of colorectal cancer is associated with prognosis.

详细描述

Colorectal cancer (CRC) is the second most commonly occurring cancer worldwide. Thirty-five percent of CRC patients are diagnosed at stage II/III, and their outcome differs even if they are in the same stage. In the "seed and soil" theory proposed by Stephen Paget, tumor cells play the role of the "seed", and the tumor microenvironment (TME) is the "soil". TNM classification provides useful but uncomplete prognosis information in colorectal cancer. It lacks the assessment of the "soil" signature of tumor microenvironment. Previous study found that the microenvironmental collagen is associated with tumor progression and metastasis. Whether tumor microenvironmental collagen signature is associated with colorectal cancer prognosis still remains unknown.

This study is a retrospective observational study performed in two centers. The main purpose of this study was to investigate whether the tumor microenvironment collagen signature (CSTME) can discriminate the 5-year DFS of stage II/III CRC patients, the secondary purpose is to compare the AUC (area under the receiver operating characteristic curve) of TNM stage+CSTME in predicting 5-year DFS with that of TNM stage alone. This study would introduce the tumor microenvironmental collagen signature into current colorectal cancer classification system, which would provide reference for clinical practice.

研究设计

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

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

  • Pathologically diagnosed with colorectal cancer
  • TNM stages II and III (according to the 8th edition of AJCC Cancer Staging Manual)
  • Received radical tumor resection surgery

排除标准

  • ASA grade 4
  • Preoperative radiotherapy and/or chemotherapy
  • Hereditary colorectal cancer
  • Pregnancy

结局指标

主要结局

5-year DFS

时间窗: 5 years followup after surgery

5-year disease free survival

次要结局

  • 5-year OS(5 years followup after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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