NCT02869269

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

July 15, 2016

Last Update Submit

January 26, 2018

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Circulating helper T cell activity

    change of expression level of T cell (0\~100 %)

    preoperative time

Secondary Outcomes (1)

  • Cytotoxic T cell and natural killer cell activity

    preoperative time

Other Outcomes (1)

  • CD4 and Treg cell activity and change of percentage of CD39 and CD73

    preoperative time

Study Arms (2)

Early stage

patients who diagnosed as TNM stage 1 and 2

Device: Early stage

Late stage

patients who diagnosed as TNM stage 3 and 4

Device: Late stage

Interventions

Early stageDEVICE

patients who classed as clinical stage 1 and 2

Also known as: stage1+2
Early stage
Late stageDEVICE

patients who classed as clinical stage 3 and 4

Also known as: stage3+4
Late stage

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing colorectal surgery

You may qualify if:

  • patient who was planned to undergo colorectal cancer surgery.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Seong-Hyop Kim, M.D,Ph.D

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 15, 2016

First Posted

August 16, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 29, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)