The Impact of Immune Cell Changes During the Perioperative Period on the Prognosis of Patients With Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Primary outcome measures
- Changes of immune cells in patients before and after surgery [Time frame: Postoperative 7 days, 30±7 days, 90 ±10 days, 365 ±30 days]
- 1-year overall survival after surgery [Time frame: Postoperative 1 year]
- 1-year disease-free survival after surgery [Time frame: Postoperative 1 year]
- 1-year recurrence-free survival after surgery [Time frame: Postoperative 1 year]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Beijing Frendship Hospital — Beijing
Identifiers
NCT: NCT05015296 · BFH-RWS-CRC