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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorBeijing Friendship Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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;

Trial 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).

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Changes of immune cells in patients before and after surgery

Preoperative lymphocyte count, postoperative lymphocyte count and normal time, recovery time.

Time frame
Postoperative 7 days, 30±7 days, 90 ±10 days, 365 ±30 days
2

1-year overall survival after surgery

the percentage of patients who survived in all patients evaluated at 1 year after surgery

Time frame
Postoperative 1 year
3

1-year disease-free survival after surgery

the percentage of patients who survived disease-free in all patients evaluated at 1 year after surgery

Time frame
Postoperative 1 year
4

1-year recurrence-free survival after surgery

the percentage of patients who survived without recurrence in all patients evaluated at 1 year after surgery

Time frame
Postoperative 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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