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临床试验/NCT02887599
NCT02887599已完成不适用

Assessment of the Cytotoxic Immune Status of Pancreatic Cancer Patients and the Severity of the Cancer Using Measurement of Natural Killer Cell Activities

Yonsei University2 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2016年8月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
2
主要终点
Difference of the cytotoxic immune status

研究概览

简要总结

Pancreatic cancer is the 5th leading cause of cancer death and the worst prognostic cancer in the world. This is due to high recurrent rate after surgical resection and poor response to chemotherapy and radiotherapy.

Recent studies revealed that peri-tumoral structure and patients' immune status including cytotoxic immunity played significant role in the bad behavior of pancreatic cancer. While past studies focused on oncogenes and tumor suppressor genes, recent studies focused on patients' own immunity. Patients' immunity modified by cancer cells is found to be correlated to cancer progression and metastasis.

Natural killer cells, playing an important role in cytotoxic immune system, are revealed to be decreased in patients with lung cancer, ovarian cancer, prostate cancer, colorectal cancer, and breast cancer. And in melanoma mouse model, when NK cell was suppressed, cancer progression and metastasis were accelerated.

This study sought to find the correlation of patients' cytotoxic immune status to cancer progression and status by measurement of NK cell activity in pancreatic cancer patients. This would be basic support to construct a prognostic model of pancreatic cancer for early metastasis and post operational recurrence.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
19 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18 and under 85
  • Control group : incidental found benign pancreatic cyst, non-neoplastic gall bladder polyp (ex, cholesterol polyp), healthy people having no evidence of malignancy in check up within 1 year
  • Patient group : histological diagnosed pancreatic cancer patients, clinically diagnosed pancreatic cancer patients by radiologic evaluation
  • Agreed to enroll the study and signed informed consent

排除标准

  • Patients with other malignancies within 5 years
  • Patients treated with steroid due to any reason within 1 year
  • Not signed informed consent

研究组 & 干预措施

Patient Group

Other

Pancreatic cancer patients

干预措施: Blood collection (Procedure)

Control Group

Other

Healthy people without evidence of malignancy

干预措施: Blood collection (Procedure)

结局指标

主要结局

Difference of the cytotoxic immune status

时间窗: 24-hour after blood collection

Difference of the cytotoxic immune status between patients group and control group by comparing quantitative measurements of NK cell activities by ELISA kit

Difference of the severity of the pancreatic cancer

时间窗: 24-hour after blood collection

Difference of the cytotoxic immune status according to the stage of the pancreatic cancer by comparing quantitative measurements of NK cell activities by ELISA kit

次要结局

  • Correlation of the cytotoxic immune status(24-hour after blood collection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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