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临床试验/NCT03422120
NCT03422120已完成不适用

Human Blood Specimen Collection to Evaluate Immune Cell Function

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
1
主要终点
Natural Killer Cell Activity (NKA) at baseline compared to POD1 in CRC surgery patients

研究概览

简要总结

Natural killer (NK) cells are leukocytes of the innate immune system and play a central role in the control of cancer metastases. NK cells and other innate immune cells often do not function well in patients with cancer and are also profoundly suppressed after cancer surgery. Dr. Auer's Lab and others have shown that NK cells are critically important in the clearance of tumor metastases and that their impairment can be recovered with immune therapy augmenting the innate immune system. Several studies suggest that cancer patients have depressed NK cell cytotoxicity as compared to healthy controls but that following resection of the cancer, NK cell cytotoxicity returns to normal levels. In this observational study, the investigators will measure NK cell cytotoxicity by the gold standard method (51Cr, a chromium51 release assay) and by a new interferon-ɣ (IFN-ɣ) based assay (NK-Vue™) in healthy humans and colorectal cancer (CRC) surgery patients seen a The Ottawa Hospital. The results of this study will determine if the NK-Vue™ is able to discriminate between healthy human volunteers and newly diagnosed cancer patients and is sufficiently sensitive to detect transient NK cell suppression immediately following surgery.

详细描述

Rationale:

The purpose of this program is to obtain consent for and to outline the process for collection of fresh blood sample from healthy humans and colorectal cancer patients before and after surgical resection.

Procurement of fresh human blood is required for the following:

  • To compare NK cell function, measured by two different assays, in healthy humans and newly diagnosed colorectal cancer patients at the Ottawa Hospital.
  • To compare NK cell function, measure by two different assays in colorectal surgery patients preoperatively and at various time points postoperatively.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Subjects who have had a recent diagnosis of cancer (any stage) and will be undergoing surgery (cancer group)
  • Subjects who are being seen by their physician for other reasons, or healthy volunteers (control group)
  • Subjects who provide informed consent to participate in the trial
  • Subjects >40 years of age

排除标准

  • 未提供

结局指标

主要结局

Natural Killer Cell Activity (NKA) at baseline compared to POD1 in CRC surgery patients

时间窗: baseline vs. Postoeprative Day (POD) 1

Measure of NK cell IFN-gamma secretion

次要结局

  • Natural Killer Cell Activity (NKA) in healthy donors (HD) as compared to colorectal cancer (CRC) patients (at baseline)(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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