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NCT Number: NCT05015296

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

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).

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Frendship Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Zhongtao Professor

CONTACT

[email protected]

86-010-63138217

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Changes of immune cells in patients before and after surgery

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

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

  2. 1-year overall survival after surgery

    Time frame: Postoperative 1 year

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

  3. 1-year disease-free survival after surgery

    Time frame: Postoperative 1 year

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

  4. 1-year recurrence-free survival after surgery

    Time frame: Postoperative 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Zhongtao Zhang, doctor

CONTACT

[email protected]

13801060364 ext. 010-63138217

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2027
Study completion
2030
First posted
Aug 20, 2021
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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