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

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.

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Key information

Conditions

Natural Killer Cell Cytokine Production Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NK Vue: NK cell activity in stimulated whole blood

Device

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

ATGen Canada Inc

Industry

Collaborators

Maisonneuve-Rosemont Hospital

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Nov 14, 2014
Registry last updated: Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed