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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Natural Killer Cell Cytokine Production

Intervention / Treatment
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* Device: NK Vue: NK cell activity in stimulated whole blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Blood drawn for NK cell activity on day of colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, natural killer cell activity, screening, NK cells