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

September 9, 2018 updated by: Song Cheol Kim, Asan Medical Center

Ex Vivo Expansion of Natural Killer Cells From Blood in Patients With Pancreatic Cancer and the Evaluation of Killing Activity of Expanded Natural Killer Cells

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Song-Cheol Kin Kim, MD, PhD.
        • Sub-Investigator:
          • Eunsung Jun, MD., PhD.
        • Sub-Investigator:
          • Hun Sik Kim, PhD

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.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pancreatic ductal adenocarcinoma Mucinous adenocarcinoma Neuroendocrine carcinoma Adenosquamous carcinoma Mucinous cystic neoplasm Intraductal mucinous neoplasm Solid pseudopapillary neoplasm Neuroendocrine tumor Serous cystic neoplasm Benign cyst Chronic pancreatitis

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NK cell activity
Time Frame: 1 month before operation
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

Outcome Measure
Measure Description
Time Frame
Tumor recurrence
Time Frame: two year after tumor diagnosis
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
Time Frame: two year after tumor diagnosis
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

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Song Cheol Kim, MD, Asan Medical Center

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 Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 9, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 9, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0865

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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