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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02291198
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : August 14, 2017
Maisonneuve-Rosemont Hospital
Information provided by (Responsible Party):
ATGen Canada Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Natural Killer Cell Cytokine Production Device: NK Vue: NK cell activity in stimulated whole blood Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1081 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Study Start Date : October 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2017

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. NK cell activity [ Time Frame: Blood drawn for NK cell activity on day of colonoscopy ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02291198

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Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
ATGen Canada Inc
Maisonneuve-Rosemont Hospital
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Principal Investigator: Gilles Jobin, MD, FRCP Maisonneuve-Rosemont Hospital
Publications of Results:
Other Publications:

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Responsible Party: ATGen Canada Inc Identifier: NCT02291198    
Other Study ID Numbers: ATG-001
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Keywords provided by ATGen Canada Inc:
colorectal cancer
natural killer cell activity
NK cells
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases