A Multicenter, Prospective, Non-interventional Real-world Study of the Impact of Immune Cell Changes During the Perioperative Period on the Prognosis of Patients With Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- 1-year overall survival after surgery
研究概览
简要总结
This is a multi-center, prospective, non-interventional real-world study. In a real-world environment, in line with the current status of the domestic diagnosis and treatment process, and on the premise of not increasing the burden of patients and medical resources, we explore the best indicators for predicting the outcome of patients with Clinical Research Coordinator (CRC) after surgery. The inclusion criteria for patients are perioperative patients with CRC. Real-world data analysis were conducted to determine whether immunization interventions versus non-interventions were able to improve patients' clinical outcomes (OS, PFS).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 years old, regardless of gender;
- •Patients with newly diagnosed CRC who are planned to undergo surgery (including patients with metastases but still feasible for surgery);
- •Patients who have not been diagnosed for the first time and have not received surgical treatment and now planned to undergo surgery(e.g., patients after neoadjuvant radiotherapy and chemotherapy for middle and low rectal cancer).
排除标准
- •Patients who refused to sign informed consent;
- •Patients complicated with other tumors;
- •Pregnant or lactating women;
- •People with a history of psychotropic drug abuse and unable to quit or those with mental disorders;
- •Postoperative histopathological examinations for patients with non-CRC type;
- •Patients who could not be followed up.
结局指标
主要结局
1-year overall survival after surgery
时间窗: Postoperative 1 year
the percentage of patients who survived in all patients evaluated at 1 year after surgery
Changes of immune cells in patients before and after surgery
时间窗: Postoperative 7 days, 30±7 days, 90 ±10 days, 365 ±30 days
Preoperative lymphocyte count, postoperative lymphocyte count and normal time, recovery time.
1-year recurrence-free survival after surgery
时间窗: Postoperative 1 year
the percentage of patients who survived without recurrence in all patients evaluated at 1 year after surgery
1-year disease-free survival after surgery
时间窗: Postoperative 1 year
the percentage of patients who survived disease-free in all patients evaluated at 1 year after surgery
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