NCT03242265

Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy

Open Label, Prospective, Cross-Sectional Clinical Performance Study of the in Vitro Diagnostic Device NK VueTM: Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: ATGen Canada Inc · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not 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 prostate cancer using prostate biopsy.

Detailed description

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 affected.

Conditions

• Immunity, Innate
• Prostatic Neoplasm

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	IVDD for NK cell activity in whole blood	Two samples of one mL of blood (for baseline IFN-gamma activity and for NK cell activity) and blood samples collected for C-Reactive Protein and White Blood Cell Count, taken up to 8 weeks prior to biopsy and before treatment with antibiotics.

Timeline

• Start date: 2017-04-04
• Primary completion: 2019-03-20
• Completion: 2019-03-20
• First posted: 2017-08-08
• Last updated: 2019-07-05

Locations

1 site across 1 country: Canada