NCT02291198

Measurement of NK Cell Activity in Whole Blood in Subjects Being Screened for Colorectal Cancer Using Colonoscopy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,081 (actual)
• Sponsor: ATGen Canada Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Natural Killer Cell Cytokine Production

Interventions

Type	Name	Description
DEVICE	NK Vue: NK cell activity in stimulated whole blood	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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-01-01
• Completion: 2017-03-01
• First posted: 2014-11-14
• Last updated: 2017-08-14

Locations

1 site across 1 country: Canada