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

January 26, 2018 updated by: Seong-Hyop Kim, Konkuk University Medical Center
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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early stage
patients who diagnosed as TNM stage 1 and 2
patients who classed as clinical stage 1 and 2
Other Names:
  • stage1+2
Late stage
patients who diagnosed as TNM stage 3 and 4
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
Time Frame: preoperative time
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
Time Frame: preoperative time
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
Time Frame: preoperative time
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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