Cytokine Changes After Colorectal Cancer Resection

NCT01244022 | Completed

• 1 other identifier: DS-P03112010
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Based on our previous research, this study aims to determine reliable surgical stress response markers in patients undergoing radical resection of colorectal cancer.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Surgical stress response; interleukins

Outcome Measures

Primary Outcomes (1)

• Postoperative changes of serum cytokine levels

  Serum cytokine levels will be determined at 1st, 2nd and 7th postoperative day and compared to preoperative values.

  1 day, 2 days and 7 days postoperatively

Secondary Outcomes (1)

• Early postoperative complications

  Within one month after surgery

Study Arms (1)

Colorectal cancer patients

Patients with pathohistologically verified colorectal cancer or adenoma with epithelial dysplasia

Procedure: colorectal cancer resection

Interventions

colorectal cancer resection PROCEDURE

Open radical resection of colorectal cancer, according to oncological principals, depending on the tumor site

Also known as: Hemicolectomy, Rectosigmoid resection

Colorectal cancer patients

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal cancer treated in the University Hospital Dubrava

You may qualify if:

• Pathohistologically verified colorectal cancer

You may not qualify if:

• Distant metastases noticed before or during surgery
• History of autoimmune diseases or immunodeficiencies
• Use of immunomodulatory drugs within 1 year prior to surgery

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University Hospital Dubrava

Zagreb, 10000, Croatia

Location

Related Publications (2)

• Servis D, Busic Z, Stipancic I, Patrlj L, Gagro A. Serum cytokine changes after gastric resection or gastrectomy for gastric cancer. Hepatogastroenterology. 2008 Sep-Oct;55(86-87):1868-72.

  PMID: 19102411 BACKGROUND

• Etherek L, Servis D, Unic A. Soluble Triggering Receptor Expressed on Myeloid Cells-1 and Inflammatory Markers in Colorectal Cancer Surgery: A Prospective Cohort Study. Chin Med J (Engl). 2017 Nov 20;130(22):2691-2696. doi: 10.4103/0366-6999.218022.

  PMID: 29133757 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

For each patient, serum samples will be stored at -80°C for later determining of serum cytokine levels

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colectomy

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Drazen Servis, M.D., Ph.D.

  University Hospital Dubrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph. D.

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 19, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

CR (1)