Open Label, Prospective, Cross-Sectional Clinical Performance Study of the in Vitro Diagnostic Device NK Vue Kit: Measurement of Natural Killer Cell Activity in Whole Blood in Subjects Being Screened for Colorectal Cancer Using Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,081
- 试验地点
- 2
- 主要终点
- NK cell activity
研究概览
简要总结
This study will look at measuring the activity of natural killer (NK) cells using the in vitro diagnostic device NK Vue in subjects being screened for colorectal cancer using colonoscopy. The NK Vue diagnostic test for natural killer cell activity uses the principle of stimulation of whole blood with a proprietary cytokine followed by the quantitative detection of interferon gamma using an immunoassay. NK Vue is intended to be used for the monitoring of the immune status of individuals. Measurement of NK cell activity could be a useful tool for assessing changes in immunosurveillance in patients with conditions or diseases where NK cell activity has been shown to be reduced, such as colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects undergoing colonoscopy at the hospital
- •Subjects who have adequately prepared for their colonoscopies as per their doctor's directions
- •Subjects whose colonoscopy preparation has been deemed to be excellent or sufficient during the colonoscopy procedure
- •Subjects who provide informed consent to participate in the trial
- •Subjects >40 years of age
排除标准
- •Lack of understanding and/or participation due to illiteracy
- •History of Active viral or bacterial infection
- •History of prescription use of immunosuppressive drugs within the last six months
- •History of anticancer treatments including surgery or chemotherapy
- •History of autoimmune disorders (rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease including Crohn's disease, Type I diabetes, Guillain-Barré syndrome)
- •Known HIV, Hepatitis B, or Hepatitis C infection
- •Currently participating (or participated within the previous 120 days) in an investigational therapeutic or device study
- •Female who is pregnant, nursing, or of child-bearing potential while not practicing effective contraceptive methods.
结局指标
主要结局
NK cell activity
时间窗: Blood drawn for NK cell activity on day of colonoscopy
Measurement of NK cell activity in subjects with cancer-negative colonoscopies versus those with pathologically confirmed colorectal cancer. Correlation of NK cell activity with polyp size, with type of adenomatous polyp and with cancer stage; measurement of the sensitivity and specificity of NK Vue; determination of the positive predictive value of NK Vue alone or in combination with the fecal immunochemical test in those subjects positive for adenomatous polyps or cancer; determination of the impact of performing both NK Vue and the fecal test on the sensitivity of the fecal test.
次要结局
未报告次要终点