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NCT04127864 Clinical Trial

Perioperative Immune Function in Patients Undergoing Colorectal Cancer Surgery

Colorectal Cancer Clinical Trial

— TruCulture  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04127864
Other study ID # TruCulture
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 14, 2019
Est. completion date June 1, 2023

Study information
Verified date August 2022
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 12
Est. completion date June 1, 2023
Est. primary completion date December 20, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Colorectal cancer surgery
All participants will undergo surgery for colorectal cancer.

Locations
Country Name City State
Denmark Center for Surgical Science, Zealand University Hospital Køge Region Zealand

Sponsors (2)
Lead Sponsor Collaborator
University of Copenhagen Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cytokines in LPS stimulated blood Difference in cytokine levels (interleukin-1b(IL-1ß), 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-?), monocyte chemoattractant protein 1 (MCP-1), Macrophage inflammatory protein-1ß (MIP-1ß), tumor necrosis factor alpha (TNF-a) 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
Primary Cytokines in CD3+CD28 stimulated blood Difference in cytokine levels (interleukin-1b(IL-1ß), 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-?), monocyte chemoattractant protein 1 (MCP-1), Macrophage inflammatory protein-1ß (MIP-1ß), tumor necrosis factor alpha (TNF-a) 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
Primary Cytokines in Poly I:P stimulated blood Difference in cytokine levels (interleukin-1b(IL-1ß), 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-?), monocyte chemoattractant protein 1 (MCP-1), Macrophage inflammatory protein-1ß (MIP-1ß), tumor necrosis factor alpha (TNF-a) 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
Primary Cytokines in R848 stimulated blood Difference in cytokine levels (interleukin-1b(IL-1ß), 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-?), monocyte chemoattractant protein 1 (MCP-1), Macrophage inflammatory protein-1ß (MIP-1ß), tumor necrosis factor alpha (TNF-a) 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 Cytokines in unstimulated blood Difference in cytokine levels (interleukin-1b(IL-1ß), 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-?), monocyte chemoattractant protein 1 (MCP-1), Macrophage inflammatory protein-1ß (MIP-1ß), tumor necrosis factor alpha (TNF-a) 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) Postoperative day 1
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