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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05015296

Enrollment

7000

Registered

2021-08-20

Start date

2021-11-23

Completion date

2030-12-31

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer, Immune Cells

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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 overall survival after surgery	Postoperative 1 year	the percentage of patients who survived 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
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

Countries

China

Contacts

CONTACTZhongtao Zhang, doctor

zhangzht@ccmu.edu.cn13801060364

Outcome results