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Clinical Trials/NCT04127864
NCT04127864
Unknown
Not Applicable

Perioperative Immune Function in Patients Undergoing Colorectal Cancer Surgery Using a Functional Whole Blood Immune Stimulation Assay

University of Copenhagen1 site in 1 country12 target enrollmentOctober 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
University of Copenhagen
Enrollment
12
Locations
1
Primary Endpoint
Cytokines in LPS stimulated blood
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 14, 2019
End Date
June 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rune Børch Hasselager

Principal Investigator

Zealand University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Age under 18
  • Neoadjuvant chemo or radiation therapy

Outcomes

Primary Outcomes

Cytokines in LPS stimulated blood

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Cytokines in unstimulated blood(Postoperative day 1)

Study Sites (1)

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