Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer
1 other identifier
interventional
218
1 country
1
Brief Summary
Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence. The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Mar 2016
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 5, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 2, 2018
March 1, 2018
9 months
September 2, 2015
March 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
CD39 and CD73 on circulating regualtory T cells
change of percentage of CD39 and CD73 (scores range from 0 to 100)
preoperative time. postoperative 1 hours and 24 hours
Secondary Outcomes (1)
Circulating natural killer cells
preoperative time. postoperative 1 hours and 24 hours
Other Outcomes (1)
Circulating type 1 and type 17 helper T cells
preoperative time. postoperative 1 hours and 24 hours
Study Arms (2)
propofol group
ACTIVE COMPARATORThe patient who anesthetized by using propofol.
sevoflurane group
ACTIVE COMPARATORThe patient who anesthetized by using propofol
Interventions
Patient will be anesthetized by using propofol infusion during operation.
Patient will be anesthetized by using sevoflurane inhalation during operation.
Eligibility Criteria
You may qualify if:
- patient who was planned to undergo colon 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seong-Hyop Kim, M.D,Ph.D
Konkuk University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 2, 2015
First Posted
October 5, 2015
Study Start
March 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
April 2, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share