Immune Cell Changes Around Surgery and Colorectal Cancer Outcomes
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
Run by Beijing Friendship Hospital · NCT05015296 · Data updated 2026-11-12
This real-world, multi-center study looks at whether perioperative immune cell changes can help predict outcomes for colorectal cancer patients undergoing surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 7000 (estimated) |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | November 23, 2021 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2030 |
| Registry record updated | July 20, 2026 |
| Trial ID | NCT05015296 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-85 with newly diagnosed colorectal cancer who are planned for surgery, including patients with resectable metastases and those after neoadjuvant therapy for rectal cancer.
✕Probably not a fit
Patients who are unwilling to give informed consent, have other active tumors, are pregnant, have certain psychiatric histories, or cannot be followed up may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, non-interventional observational study conducted at Beijing Friendship Hospital to explore real-world immune indicators around the perioperative period in colorectal cancer patients. The study analyzes whether perioperative immune changes predict overall survival and progression-free survival. Data will come from patients treated under routine clinical pathways, without adding burdens to patients or resources. The aim is to identify the best indicators to forecast prognosis in patients after surgery, including those with metastases who are still operable.
Why it matters
Potential benefit: If successful, the study could identify immune markers that help predict prognosis and guide perioperative care for colorectal cancer patients.
How similar studies have gone: Prior observational work suggests immune changes can be associated with cancer outcomes, but this exact perioperative immune marker strategy is relatively novel in colorectal cancer.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Beijing Frendship Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Zhongtao Zhang, doctor
- Email: zhangzht@ccmu.edu.cn
- Phone: 13801060364
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.