Immunological and Oxidative Stress Response in Relation to Abdominal Cancer Surgery

NCT03473327 | Completed

• 1 other identifier: IMOX
• Study Type: observational
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to characterize the systemic stress response (SSR) induced in patients undergoing colorectal cancer (CRC) surgery. The project is a clinical prospective study. Blood samples will be collected from 30 patients on the day before CRC-surgery, and 1, 2, 3 and 10 days after surgery. A specimen from the resected tumor tissue will also be collected and sent for immunohistochemical analysis. Whole blood gene expression profiling will be performed to gain knowledge of the genetic changes in immunological, inflammatory and oxidative stress-related factors initiated by surgery. Peripheral immunological cells, proteins and cytokines will be analysed by FLOW and ELISA methods, and the functional capacity of NK-cells will also be defined for each time point. Furthermore, tumor tissue will be analyzed for invasion of immunological cells. At each time point, the patients will be asked to fill out a validated patient reported outcome measure with questions concerning clinical outcome parameters related to recovery after CRC-surgery

Conditions

Colorectal Neoplasms

Keywords

colorectal neoplasms; Immunologic Factors; Postoperative Period

Outcome Measures

Primary Outcomes (1)

• Oxidative and immunological gene-expression before and after laparoscopic surgery for colon cancer using whole blood gene expression profiling from blood samples

  The most significantly differentially expressed probe sets will be chosen for further analysis. Examples of exact genes will be genes encoding for TNFα, IL-1b, IL-2, IL-6, IL-10, VEGF, TGFβ and HLA-G. Within oxidative and antioxidative genes, special emphasis will be taken in FoxO3, TP53 and ATM.

  1 year

Secondary Outcomes (2)

• Specific immune modulating proteins in blood before and after laparoscopic surgery for colon cancer, using flow cytometry and NK-cell isolation from blood samples

  1 year

• Assessement of inflammatory tumor invasion using immunohistochemestry on tumor tissue samples

  1 year

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 patients undergoing elective, laparoscopic hemicholectomy for Colon cancer UICC stadium II-III.

You may qualify if:

• Patients between 18 to 75 years of age
• Patients diagnosed with colon cancer (UICC stadium II-III) and scheduled for laparoscopic hemicolectomy.
• ASA class I-III (Classification of the American Society of Anesthesiology)
• Signed informed consent

You may not qualify if:

• Known immune-defects
• Withdrawal of informed consent

Sponsors & Collaborators

• Zealand University Hospital: lead
• Odense University Hospital: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for Whole Blood genomic profiling

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 Design

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

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 22, 2018
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share