Chinese Colorectal Cancer Database
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200,000
- 试验地点
- 1
- 主要终点
- local recurrence rate
研究概览
简要总结
- To establish the Chinese people's own clinical data database of colorectal cancer, reflecting the law and characteristics of colorectal cancer patients in China.
- Based on colorectal cancer surgery, collect clinical data, especially data on clinical manifestations, complications, laboratory tests, auxiliary examinations, postoperative clinical effects, surgical complications, and colorectal cancer recurrence, so as to lead the direction of clinical practice and academic research of colorectal cancer surgery in China. It provides a certain basis for future research on colorectal cancer.
- Provide academic consultation and data support to national health authorities.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adenocarcinoma of the colon by biopsy
- •tolerable to surgery
- •be able to understand and willing to participate in this trial with signature
排除标准
- •can not tolerate the surgery
- •history of serious mental illness
- •the researchers believe the patients should not enrolled in
结局指标
主要结局
local recurrence rate
时间窗: 3 years after surgery
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
disease free survival rate
时间窗: 3-year after surgery
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
the rate of postoperative complications
时间窗: 30 days after surgery
preoperative safety containing operation information, complication information.
Positive rate of circumferential resection margin (CRM) of the specimens
时间窗: 10 days after surgery
Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while \>1mm is negative.
The grade score of the specimens integrity
时间窗: 10 days after surgery
shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see \>5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
The distance between lower tumor margin and the lower reaction margin
时间窗: 10 days after surgery
shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.
postoperative hospital stay
时间窗: 3 year after surgery
recovery information.
the score of postoperative life
时间窗: 6 months after surgery
quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function.
the operative time
时间窗: 30 days after surgery
preoperative safety containing operation information, complication information.
overall survival rate
时间窗: 3-year after surgery
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
次要结局
未报告次要终点
研究者
Zhongtao Zhang
Director of general surgery, principal investigato
Beijing Friendship Hospital