- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02758249
Anesthetic Effect on Immune Cell in Patients With Cancer
Anesthetics agents has an effect on immune response during the cancer surgery.This influence can regulatory to immune activity or cancer cell survival.
The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.
Study Overview
Detailed Description
The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.
- immediate before anesthesia induction
- postoperative 1 hours
- postoperative 24 hours
Immune cells isolation from patients peripheral blood mononuclear cells. Next, immune cell were co-culture with human cancer cell line (MCF-7) for 24 hours. investigation for immune cell or cancer cell survival by flow cytometry.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 143-729
- Konkuk University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patient who was planned to undergo breast 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?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: sevoflurane
patients under sevoflurane anesthesia
|
patients are anesthetized by using sevoflurane inhalation
|
|
Active Comparator: propofol
patients under propofol anesthesia
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patients are anesthetized by using propofol infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
immune cell (NK cell and CD8+ T cell)
Time Frame: up to 24 hours
|
Patients blood sample are collect up to 24 hours postoperatively.
These blood sample are collect in EDTA tube for NK cell and CD8+ T cell isolation from peripheral blood mononuclear cells (PBMCs).
Isolation for NK cell, Ab stain with CD16 and CD56.
Also, isolation for CD8+ T cell, Ab stain with CD8, that are purified from PBMCs, using FACSAria according to the manufacturer's protocol.
These cell are culture with MCF-7 cancer cell line for 24 hours.
After 24h, the degree of apoptosis of NK cell and CD8+ T cell was determined by flow cytometry.
Suspension cell is NK cell or CD8+ T cell, these cells were harvest and washed with cell staining buffer.
After washing, cell resuspended with Annexin-V binding buffer and stained with FITC-Annexin-V according to the manufacturer's protocol with analysis
|
up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cancer cell (MCF-7) apoptosis
Time Frame: Baseline. postoperative 1 hours and 24 hours
|
Patients blood sample are collect before and 1h after anesthesia induction and at 24h postoperatively.
These blood sample are collect in EDTA tube for NK cell and CD8+ T cell isolation from peripheral blood mononuclear cells (PBMCs).
Isolation for NK cell, Ab stain with CD16 and CD56.
Also, isolation for CD8+ T cell, Ab stain with CD8, that are purified from PBMCs, using FACSAria according to the manufacturer's protocol.
These cell are culture with MCF-7 cancer cell line for 24 hours.
After 24h, the degree of apoptosis of cancer cell was determined by flow cytometry.
Adherent cell is cancer cell, these cells were harvest and washed with cell staining buffer.
After washing, cell resuspended with Annexin-V binding buffer and stained with FITC-Annexin-V according to the manufacturer's protocol with analysis
|
Baseline. postoperative 1 hours and 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seong-Hyop Kim, M.D., Ph.D., Konkuk University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUH1160098
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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