The Impact of Immune Cell Changes During the Perioperative Period on the Prognosis of Patients With Colorectal Cancer

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of immune cells in patients before and after surgery | Preoperative lymphocyte count, postoperative lymphocyte count and normal time, recovery time. | Postoperative 7 days, 30±7 days, 90 ±10 days, 365 ±30 days | 
| 1-year overall survival after surgery | the percentage of patients who survived in all patients evaluated at 1 year after surgery | Postoperative 1 year | 
| 1-year disease-free survival after surgery | the percentage of patients who survived disease-free in all patients evaluated at 1 year after surgery | Postoperative 1 year | 
| 1-year recurrence-free survival after surgery | the percentage of patients who survived without recurrence in all patients evaluated at 1 year after surgery | Postoperative 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Immune Cells