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Perioperative Immune Function in Patients Undergoing Colorectal Cancer Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04127864
Acronym
TruCulture
Enrollment
12
Registered
2019-10-16
Start date
2019-10-14
Completion date
2023-06-01
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Surgery

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.

Interventions

All participants will undergo surgery for colorectal cancer.

Sponsors

Zealand University Hospital
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* Age under 18 * Neoadjuvant chemo or radiation therapy

Design outcomes

Primary

MeasureTime frameDescription
Cytokines in LPS stimulated bloodPostoperative day 1Difference 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 bloodPostoperative day 1Difference 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 bloodPostoperative day 1Difference 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 bloodPostoperative day 1Difference 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

MeasureTime frameDescription
Cytokines in unstimulated bloodPostoperative day 1Difference 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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026