Evaluation Of Killing Activity Of Expanded Natural Killer Cells From Blood In Patients With Pancreatic Cancer

Study Overview

Evaluation of Killing Activity of Expanded Natural Killer Cells From Blood in Patients With Pancreatic Cancer

Pancreatic cancer, one of the deadliest epithelial malignancies, has a 5-year survival rate of only about 8%. The mortality rate has decreased slightly, but the incidence rate has been steadily increasing, and it is predicted to be the second leading cause of cancer mortality in 2030. Early diagnosis of pancreatic cancer and the development of innovative therapies are needed, and various basic and clinical studies based on pancreatic cancer biology are underway. Recently, studies on the effect of natural killer (NK) cells on cancer progression and the development of therapeutic agents using them have been actively conducted. NK cells are a component of innate lymphoid cells, accounting for approximately 5-15% of total peripheral blood mononuclear cells (PBMC).

Investigators will apply a new method to evaluate the activity of NK cells in pancreatic cancer patients, and to analyze the correlation with the progression of the tumor and the prognosis of the patient. And investigators will analyze the multifactorial factors affecting the activity of NK cells and conducted this study to help establish new diagnostic and therapeutic strategies for pancreatic cancer.

Pancreatic Neoplasms

DIAGNOSTIC_TEST: Receptor specific activation method

2015-0865

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-09-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-09-09
First Submitted that Met QC Criteria 2018-09-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-09-11
First Posted (ACTUAL) 2018-09-11	Results First Posted N/A	Last Verified 2018-09

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Conventional Activation method NK cell was incubated with either K562 cells	DIAGNOSTIC_TEST: Receptor specific activation method NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4
: Receptor specific activation method NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4	DIAGNOSTIC_TEST: Receptor specific activation method NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4

Participant Group/Arm

Intervention/Treatment

: Conventional Activation method

NK cell was incubated with either K562 cells

DIAGNOSTIC_TEST: Receptor specific activation method

NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4

: Receptor specific activation method

NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4

DIAGNOSTIC_TEST: Receptor specific activation method

NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4

Primary Outcome Measures	Measure Description	Time Frame
NK cell activity	In order to compare the activity of NK cells according to the activation method, NK cells obtained from the blood of participants will be analyzed. Investigates will use two methods to analysis the activity of NK cell by FACS (Fluorescence-activated cell sorting). The degree of expression of CD107a on the cell surface and the degree of IFN-γ secretion will be compared by FACS.	1 month before operation

Secondary Outcome Measures	Measure Description	Time Frame
Tumor recurrence	In order to analyze the correlation of NK cell activity with the prognosis of the participants, investigators will follow up the recurrence of the tumor. This will be analyzed with the activity of NK cell.	two year after tumor diagnosis
Survival of participants	In order to analyze the correlation of NK cell activity with the prognosis of the participants, investigators will follow up the survival of the patients. This will be analyzed with the activity of NK cell.	two year after tumor diagnosis

Contacts and Locations

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

Study Contact

Name: Eunsung Jun, MD

Phone Number: 2-3010-1696

Email: go1040@hanmail.net

Study Contact Backup

Name: Song Cheol Kim, MD

Phone Number: 2-3010-3936

Email: drksc@amc.seoul.kr

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:
1

The patient who is admitted to the pancreatic surgery department for the treatment of pancreas tumor
Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
Life expectancy of at least 6 months based on discretion of treating
Adequate hematologic function defined by the following laboratory parameters: Hemoglobin > 100, Platelet count > 100 and Absolute granulocyte count > 1.5.

Patients who received preoperative chemotherapy or radiotherapy.
Previous or concurrent malignancies.
Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, serous infection.

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Song Cheol Kim, MD, Asan Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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