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Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery

2021年7月14日更新者：Second Affiliated Hospital, School of Medicine, Zhejiang University

Background:

. The incidence and mortality of colon cancer are high in China and in the world.
. The treatment of many patients in the real world is not standardized, and there are problems such as over-treatment or under-treatment. To explore the adjuvant treatment of colon cancer in the Chinese population, this study will retrospectively analyze real-world data on adjuvant therapy for colon cancer in Chinese patients after radical surgery.

The purpose of research:

. Current status of adjuvant therapy for stage II-III colon cancer in the real world: chemotherapy regimen, chemotherapy time, efficacy, safety, etc.
. Comparison of efficacy and safety of different adjuvant chemotherapy time (<3 months vs. >=3 months) in high-risk stage II and III colon cancer patients in the real world
. Comparison of efficacy and safety of different adjuvant chemotherapy regimens (XELOX vs. FOLFOX) in high-risk stage II and III colon cancer patients in the real world

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (预期的)

20000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Ying Yuan, Ph.D&MD
电话号码：+86-571-87784795
邮箱：yuanying1999@zju.edu.cn

学习地点

中国
- Jiangsu
  - Nanjing、Jiangsu、中国
    - 招聘中
    - Jiangsu Province People Hospital
    - 接触：
      
      Yanhong Gu, MD
- Shanghai
  - Shanghai、Shanghai、中国
    - 招聘中
    - Changhai Hospital of Shanghai
    - 接触：
      
      Wei Zhang, MD
- Zhejinag
  - Hangzhou、Zhejinag、中国、310009
    - 招聘中
    - SAHZU
    - 接触：
      
      Ying Yuan, Ph.D & MD
      
      邮箱：yuanying1999@zju.edu.cn
    - 接触：
      
      Ying Yuan
      
      邮箱：yuanying1999@zju.edu.cn

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

20000 patients diagnosed with stage II-III colon cancer and undergo radical surgery since January 2010.

The demographic analysis of this study will include but limited in：

Demographic characteristics (age, gender, height, weight),
Clinical information (Site, TNM(Tumor, regional lymph Node, Metastasis) staging, CEA(Carcinoembryonic Antigen), imaging findings, patient ECOG(Eastern Cooperative Oncology Group)score, PS(Performance Status) score),
Pathology information (MMR(Mismatch Repair) status, RAS status, BRAF status, HER2 status, Lymph node, Number of detections, Nerve infiltration, Vascular invasion, Histological type, etc.)

描述

Inclusion Criteria:

Patients who are sick after January 2010
Age is older than 18
Surgical pathology confirmed TNM stage II-III (AJCC 7th edition) colon cancer

Exclusion Criteria:

Combine other tumors
Pathological information is not clear
Researchers believe that other reasons are not suitable for enrollment

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer 大体时间：From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.	Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer	From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Percentage of patients with different chemotherapy time for adjuvant therapy for stage II and stage III colon cancer 大体时间：From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.	Percentage of patients with different chemotherapy time for adjuvant therapy for stage II and stage III colon cancer	From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Percentage of Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer 大体时间：From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.	Percentage of Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer	From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Second Affiliated Hospital, School of Medicine, Zhejiang University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年11月9日

初级完成 (预期的)

2022年10月15日

研究完成 (预期的)

2023年12月15日

研究注册日期

首次提交

2018年12月25日

首先提交符合 QC 标准的

2019年5月19日

首次发布 (实际的)

2019年5月22日

研究记录更新

最后更新发布 (实际的)

2021年7月15日

上次提交的符合 QC 标准的更新

2021年7月14日

最后验证

2021年5月1日