Clinical trial NCT03665571: Evaluation of Killing Activity of Expanded Natural Killer Cells From Blood in Patients With Pancreatic Cancer
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neoplasms
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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).

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.

Eligibility 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.

Primary outcomes:
measure: NK cell activity
timeFrame: 1 month before operation
Secondary outcomes:
measure: Tumor recurrence
timeFrame: two year after tumor diagnosis
measure: Survival of participants
timeFrame: two year after tumor diagnosis
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Song Cheol Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: