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

NCT05015296 | Recruiting

• 1 other identifier: BFH-RWS-CRC
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; Immune Cells

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Frendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Zhongtao Zhang, doctor

CONTACT

13801060364; zhangzht@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of general surgery, principal investigato

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 20, 2021
• Study Start: November 23, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

CN (1)