A Study of Circulating Immune Cell Activity Changes in Blood of Colorectal Cancer Patients

Previous studies have shown that colorectal cancer patients' prognosis and overall survival was related with immune cell expression in patients' tissue. However, the circulating immune cell activity changes in patients' blood has few studies. The purpose of this study is to analyze the variation of circulating immune cell activity in colorectal patients' blood which is classed as clinical staging.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: Early stage; Device: Late stage

Detailed Description

The patients were classed as clinical staging

1. Early (stage1+2) and Late(stage3+4)
2. regional lymph node metastasis
3. Distant metastasis
4. TNM stage

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing colorectal surgery

Description

Inclusion Criteria:

• patient who was planned to undergo colorectal cancer surgery.

Exclusion Criteria:

• age < 20 years old
• history of hypersensitivity reaction in propofol or sevoflurane
• history of previous cancer
• patient with ongoing inflammation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early stage; patients who diagnosed as TNM stage 1 and 2	Device: Early stage; patients who classed as clinical stage 1 and 2; Other Names: stage1+2
Late stage; patients who diagnosed as TNM stage 3 and 4	Device: Late stage; patients who classed as clinical stage 3 and 4; Other Names: stage3+4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating helper T cell activity	change of expression level of T cell (0~100 %)	preoperative time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytotoxic T cell and natural killer cell activity	change of expression level Cytotoxic T cell and natural killer cell(0~100 %)from 0 to 100)	preoperative time

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD4 and Treg cell activity and change of percentage of CD39 and CD73	change of expression level of CD4 and Treg cell activity and change of percentage of CD39 and CD73(0~100 %)	preoperative time

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: KUH1160096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO