CompletedNot Applicable

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

Canada1,081 participantsStarted 2014-10

Plain-language 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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

NK cell activity

Timeframe: Blood drawn for NK cell activity on day of colonoscopy

Trial details

NCT IDNCT02291198

SponsorATGen Canada Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Natural Killer Cell Cytokine Production trials