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

Not yet recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT05015296
• Lead Sponsor: Beijing Friendship Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-19
• Last Update Submitted: 2021-08-19
• Study First Posted: 2021-08-20
• Last Update Posted: 2021-08-20
• Study Start: 2021-09
• Primary Completion: 2022-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

1. 18-85 years old, regardless of gender;
2. Patients with newly diagnosed CRC who are planned to undergo surgery (including patients with metastases but still feasible for surgery);
3. 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

1. Patients who refused to sign informed consent;
2. Patients complicated with other tumors;
3. Pregnant or lactating women;
4. People with a history of psychotropic drug abuse and unable to quit or those with mental disorders;
5. Postoperative histopathological examinations for patients with non-CRC type;
6. Patients who could not be followed up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1-year overall survival after surgery	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	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	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	Postoperative 1 year	the percentage of patients who survived disease-free in all patients evaluated at 1 year after surgery