Perioperative Immune Function in Patients Undergoing Colorectal Cancer Surgery

NCT04127864 | Unknown DMC

• 1 other identifier: TruCulture
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Surgery

Outcome Measures

Primary Outcomes (4)

• Cytokines in LPS stimulated blood

  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)

  Postoperative day 1

• Cytokines in CD3+CD28 stimulated blood

  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)

  Postoperative day 1

• Cytokines in Poly I:P stimulated blood

  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)

  Postoperative day 1

• Cytokines in R848 stimulated blood

  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)

  Postoperative day 1

Secondary Outcomes (1)

• Cytokines in unstimulated blood

  Postoperative day 1

Interventions

Colorectal cancer surgery PROCEDURE

All participants will undergo surgery for colorectal cancer.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for minimally invasive colorectal cancer resection at Zealand University Hospital. They will undergo standard treatment characterized by strict adherence to the enhanced recovery after surgery guidelines

You may qualify if:

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

You may not qualify if:

• Age under 18
• Neoadjuvant chemo or radiation therapy

Sponsors & Collaborators

• University of Copenhagen: lead
• Zealand University Hospital: collaborator

Study Sites (1)

Center for Surgical Science, Zealand University Hospital

Køge, Region Sjælland, DK4600, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ismail Gögenur, DMSc

  Center for Surgical Science, Zealand University Hospital, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: October 14, 2019
• Primary Completion: December 20, 2019
• Study Completion: June 1, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

DK (1)