Perioperative Immune Function in Patients Undergoing Colorectal Cancer Surgery

• Conditions: Colorectal Cancer; Surgery

• Registration Number: NCT04127864
• Lead Sponsor: University of Copenhagen

Brief Summary

At Zealand University Hospital, Denmark, the investigators will examine the immune function of patients with colorectal cancer before and after tumor resection.

The immune function will be assessed with functional profiling of the immune function (TruCulture®)

The study aims to describe alterations in the perioperative immune response to surgery. The generatied knowledge will lead to better under standing of perioperative pathophysiology.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-14
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Primary Completion: 2019-12-20
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-05
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients scheduled for laparoscopic resection of colorectal cancer with curative intent

Exclusion Criteria

• Age under 18
• Neoadjuvant chemo or radiation therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cytokines in LPS stimulated blood	Postoperative day 1	Difference in cytokine levels (interleukin-1b(IL-1β), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-5 (IL-5), interleukin-6 (IL-6), interleukin-7 (IL-7), interleukin-8 (IL-8), interleukin-10 (IL-10), interleukin-12 70p (IL-12 (70)), interleukin-13 (IL-13), interleukin-17 (IL-17), Granulocyte colony-stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF) interpheron-gamme (IFN-γ), monocyte chemoattractant protein 1 (MCP-1), Macrophage inflammatory protein-1β (MIP-1β), tumor necrosis factor alpha (TNF-α) all pg/ml) between postoperative and preoperative whole blood exposed to lipopolysaccharide measured with multiplex assay (Bio-Plex Pro™ Human Cytokine 17-plex Assay (M50-00031YV) by Bio-Rad)
Cytokines in CD3+CD28 stimulated blood	Postoperative day 1	Difference in cytokine levels (interleukin-1b(IL-1β), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-5 (IL-5), interleukin-6 (IL-6), interleukin-7 (IL-7), interleukin-8 (IL-8), interleukin-10 (IL-10), interleukin-12 70p (IL-12 (70)), interleukin-13 (IL-13), interleukin-17 (IL-17), Granulocyte colony-stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF) interpheron-gamme (IFN-γ), monocyte chemoattractant protein 1 (MCP-1), Macrophage inflammatory protein-1β (MIP-1β), tumor necrosis factor alpha (TNF-α) all pg/ml) between postoperative and preoperative whole blood exposed to CD3 and CD28 measured with multiplex assay (Bio-Plex Pro™ Human Cytokine 17-plex Assay (M50-00031YV) by Bio-Rad)
Cytokines in Poly I:P stimulated blood	Postoperative day 1	Difference in cytokine levels (interleukin-1b(IL-1β), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-5 (IL-5), interleukin-6 (IL-6), interleukin-7 (IL-7), interleukin-8 (IL-8), interleukin-10 (IL-10), interleukin-12 70p (IL-12 (70)), interleukin-13 (IL-13), interleukin-17 (IL-17), Granulocyte colony-stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF) interpheron-gamme (IFN-γ), monocyte chemoattractant protein 1 (MCP-1), Macrophage inflammatory protein-1β (MIP-1β), tumor necrosis factor alpha (TNF-α) all pg/ml) between postoperative and preoperative whole blood exposed to Polyinosinic:polycytidylic acid measured with multiplex assay (Bio-Plex Pro™ Human Cytokine 17-plex Assay (M50-00031YV) by Bio-Rad)
Cytokines in R848 stimulated blood	Postoperative day 1	Difference in cytokine levels (interleukin-1b(IL-1β), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-5 (IL-5), interleukin-6 (IL-6), interleukin-7 (IL-7), interleukin-8 (IL-8), interleukin-10 (IL-10), interleukin-12 70p (IL-12 (70)), interleukin-13 (IL-13), interleukin-17 (IL-17), Granulocyte colony-stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF) interpheron-gamme (IFN-γ), monocyte chemoattractant protein 1 (MCP-1), Macrophage inflammatory protein-1β (MIP-1β), tumor necrosis factor alpha (TNF-α) all pg/ml) between postoperative and preoperative whole blood exposed to Resiquimod (R848) measured with multiplex assay (Bio-Plex Pro™ Human Cytokine 17-plex Assay (M50-00031YV) by Bio-Rad)

Secondary Outcome Measures

Name	Time	Method
Cytokines in unstimulated blood	Postoperative day 1	Difference in cytokine levels (interleukin-1b(IL-1β), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-5 (IL-5), interleukin-6 (IL-6), interleukin-7 (IL-7), interleukin-8 (IL-8), interleukin-10 (IL-10), interleukin-12 70p (IL-12 (70)), interleukin-13 (IL-13), interleukin-17 (IL-17), Granulocyte colony-stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF) interpheron-gamme (IFN-γ), monocyte chemoattractant protein 1 (MCP-1), Macrophage inflammatory protein-1β (MIP-1β), tumor necrosis factor alpha (TNF-α) all pg/ml) between postoperative and preoperative plasma measured with multiplex assay (Bio-Plex Pro™ Human Cytokine 17-plex Assay (M50-00031YV) by Bio-Rad)

Trial Locations

Locations (1)

Center for Surgical Science, Zealand University Hospital; 🇩🇰 Køge, Region Zealand, Denmark