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

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ClinicalTrials.gov Identifier: NCT03665571
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Song Cheol Kim, Asan Medical Center

Brief 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).

Condition or disease Intervention/treatment
Pancreatic Neoplasms Diagnostic Test: Receptor specific activation method

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 [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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
Actual Study Start Date : July 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples Without DNA
Natural killer cell and plasma from peripheral blood.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665571


Contacts
Contact: Eunsung Jun, MD 2-3010-1696 go1040@hanmail.net
Contact: Song Cheol Kim, MD 2-3010-3936 drksc@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Eunsung Jun, MD., PhD.    82-2-3010-1696    go1040@hanmail.net   
Principal Investigator: Song-Cheol Kin Kim, MD, PhD.         
Sub-Investigator: Eunsung Jun, MD., PhD.         
Sub-Investigator: Hun Sik Kim, PhD         
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Song Cheol Kim, MD Asan Medical Center

Responsible Party: Song Cheol Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03665571     History of Changes
Other Study ID Numbers: 2015-0865
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases