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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05015296
• Other study ID #: BFH-RWS-CRC
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: August 1, 2025

Study information

• Verified date: August 2021
• Source: Beijing Friendship Hospital
• Contact: Zhongtao Zhang, doctor
• Phone: 13801060364
• Email: zhangzht[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	1-year overall survival after surgery	the percentage of patients who survived in all patients evaluated at 1 year after surgery	Postoperative 1 year
Primary	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
Primary	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