An interventional study of NK Vue: NK cell activity in stimulated whole blood in Natural Killer Cell Cytokine Production, sponsored by ATGen Canada Inc. Completed at 1 site in Canada. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-14.
Sponsored by ATGen Canada Inc · Not applicable, Interventional, and Screening
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 1,081 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
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One mL of blood is collected from each subject, on the day of colonoscopy, using NK Vue Promoca Tubes blood collection tubes containing a proprietary stimulating cytokine. After incubation, NK cell activity is measured in the collected plasma using an ELISA.
NK cell activity
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.
Time frame: Blood drawn for NK cell activity on day of colonoscopy
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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ATGen Canada Inc