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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03665571
• Other study ID #: 2015-0865
• Status: Recruiting
• Start date: July 2016
• Est. completion date: October 2019

Study information

• Verified date: September 2018
• Source: Asan Medical Center
• Contact: Eunsung Jun, MD
• Phone: 2-3010-1696
• Email: go1040[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• Receptor specific activation method
NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-? secretion will be compared by FACS.	1 month before operation
Secondary	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
Secondary	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