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临床试验/NCT02635087
NCT02635087招募中不适用

microRNAs Tool for Stratifying Stage II Colon Cancer:a Perspective Study of Adjuvant Chemotherapy

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
630
试验地点
1
主要终点
DFS

研究概览

简要总结

The investigators discover the investigators' miRNA tool can be a useful tool to predict the patients with stage II colon who can benefit from chemotherapy.Then the investigators plan to make an observation study that may validation this tool.

详细描述

This is an observation study. The investigators recruit patients who agree to use their postoperative specimen for miRNA tool examination and receive the investigators' follow up.Their receiving chemotherapy or not will decided by their doctors. The investigators just see whether the stratifying tool could predict prognosis.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The informed consent has been obtained from the patient.
  • With confirmed diagnosis of stage II colon cancer.
  • With moderate/good ECOG health rating (PS): 0-1 score.
  • The patient receive no anti-cancer treatment before primary surgery.
  • The patient receive radical operation for colon cancer with negative margin.

排除标准

  • With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
  • With bad compliance or contraindication to enrollment.
  • Pregnant woman or lactating woman.
  • With contraindication to receive adjuvant chemotherapy.

结局指标

主要结局

DFS

时间窗: 3 years

次要结局

  • OS(5 years)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wu Song

archiater

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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