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
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- NK cell activity
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
NK cell activity
时间窗: 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.
次要结局
- Survival of participants(two year after tumor diagnosis)
- Tumor recurrence(two year after tumor diagnosis)
研究者
Song Cheol Kim
Professor
Asan Medical Center