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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 10000
- Primary Endpoint
- 1-year overall survival after surgery
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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).
Investigators
Zhongtao Zhang
Director of general surgery, principal investigato
Beijing Friendship Hospital
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1-year overall survival after surgery
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Postoperative 1 year
the percentage of patients who survived disease-free in all patients evaluated at 1 year after surgery