A Study of Circulating Immune Cell Activity Changes in Bl... | NCT02869269

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

NCT02869269

Sponsor

Konkuk University Medical Center

Status

Completed

Last Update Posted

Jan 29, 2018Actual

Enrollment

67Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Early stage
Late stage

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Jul 15, 2016

First Submission Date that Met QC Criteria

Aug 11, 2016

First Posted Date

Aug 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2018

Last Update Posted Date

Jan 29, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seong-Hyop Kim, Associate professor, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The patients were classed as clinical staging

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Early stage	Device	patients who classed as clinical stage 1 and 2	Early stage

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing colorectal surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seong-Hyop Kim, M.D,Ph.D	Konkuk University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Konkuk University Medical Center		Seoul		143-729	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided