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

NCT03665571 | Unknown DMC

• 1 other identifier: 2015-0865
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tumor recurrence

  two year after tumor diagnosis

• Survival of participants

  two year after tumor diagnosis

Study Arms (2)

Conventional Activation method

NK cell was incubated with either K562 cells

Diagnostic Test: Receptor specific activation method

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

Interventions

Receptor specific activation method DIAGNOSTIC_TEST

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

Conventional Activation method; Receptor specific activation method

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Natural killer cell and plasma from peripheral blood.

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Song Cheol Kim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunsung Jun, MD

CONTACT

2-3010-1696; go1040@hanmail.net

Song Cheol Kim, MD

CONTACT

2-3010-3936; drksc@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 11, 2018
• Study Start: July 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2019
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

KR (1)