Clinical trial NCT05015296: The Impact of Immune Cell Changes During the Perioperative Period on the Prognosis of Patients With Colorectal Cancer
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Immune Cells
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Changes of immune cells in patients before and after surgery
timeFrame: Postoperative 7 days, 30±7 days, 90 ±10 days, 365 ±30 days
measure: 1-year overall survival after surgery
timeFrame: Postoperative 1 year
measure: 1-year disease-free survival after surgery
timeFrame: Postoperative 1 year
measure: 1-year recurrence-free survival after surgery
timeFrame: Postoperative 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: