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

Official Title

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

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.

Trial Description

Primary Outcome:

  • The ability of NK cell activity to predict prostate cancer (yes/no) on biopsy
Secondary Outcome:
  • The ability of NK cell activity to predict tumour grade (Gleason 2-6 vs. no cancer; Gleason 7-10 vs. no cancer)
  • Test performance metrics of NK Vue and PSA (each alone)
  • Impact of combination of NK Vue and PSA on the test performance of PSA
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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society