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

ATGen

Status

Completed

Conditions

Natural Killer Cell Cytokine Production

Treatments

Device: NK Vue: NK cell activity in stimulated whole blood

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02291198

ATG-001

Details and patient eligibility

About

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.

Enrollment

1,081 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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.