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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Zhongtao Zhang, doctor; Phone Number: 010-63138217 13801060364; Email: zhangzht@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Immune Cells
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: BFH-RWS-CRC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No