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

NCT ID: NCT02291198

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1081 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-03-31

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.

Conditions

Natural Killer Cell Cytokine Production

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: collaborator

ATGen Canada Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles Jobin, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Countries

Canada

References

Lee SB, Cha J, Kim IK, Yoon JC, Lee HJ, Park SW, Cho S, Youn DY, Lee H, Lee CH, Lee JM, Lee KY, Kim J. A high-throughput assay of NK cell activity in whole blood and its clinical application. Biochem Biophys Res Commun. 2014 Mar 14;445(3):584-90. doi: 10.1016/j.bbrc.2014.02.040. Epub 2014 Feb 18.

Reference Type: BACKGROUND

PMID: 24561245 (View on PubMed)

Koo KC, Shim DH, Yang CM, Lee SB, Kim SM, Shin TY, Kim KH, Yoon HG, Rha KH, Lee JM, Hong SJ. Reduction of the CD16(-)CD56bright NK cell subset precedes NK cell dysfunction in prostate cancer. PLoS One. 2013 Nov 4;8(11):e78049. doi: 10.1371/journal.pone.0078049. eCollection 2013.

Reference Type: BACKGROUND

PMID: 24223759 (View on PubMed)

Kim JC, Choi J, Lee SJ, Lee YA, Jeon YM, Kang YW, Lee JK. Evaluation of cytolytic activity and phenotypic changes of circulating blood immune cells in patients with colorectal cancer by a simple preparation of peripheral blood mononuclear cells. J Korean Surg Soc. 2013 Nov;85(5):230-5. doi: 10.4174/jkss.2013.85.5.230. Epub 2013 Oct 25.

Reference Type: BACKGROUND

PMID: 24266014 (View on PubMed)

Furue H, Matsuo K, Kumimoto H, Hiraki A, Suzuki T, Yatabe Y, Komori K, Kanemitsu Y, Hirai T, Kato T, Ueda M, Ishizaki K, Tajima K. Decreased risk of colorectal cancer with the high natural killer cell activity NKG2D genotype in Japanese. Carcinogenesis. 2008 Feb;29(2):316-20. doi: 10.1093/carcin/bgm260. Epub 2008 Jan 3.

Reference Type: BACKGROUND

PMID: 18174257 (View on PubMed)

Hayashi T, Imai K, Morishita Y, Hayashi I, Kusunoki Y, Nakachi K. Identification of the NKG2D haplotypes associated with natural cytotoxic activity of peripheral blood lymphocytes and cancer immunosurveillance. Cancer Res. 2006 Jan 1;66(1):563-70. doi: 10.1158/0008-5472.CAN-05-2776.

Reference Type: BACKGROUND

PMID: 16397273 (View on PubMed)

Imai K, Matsuyama S, Miyake S, Suga K, Nakachi K. Natural cytotoxic activity of peripheral-blood lymphocytes and cancer incidence: an 11-year follow-up study of a general population. Lancet. 2000 Nov 25;356(9244):1795-9. doi: 10.1016/S0140-6736(00)03231-1.

Reference Type: BACKGROUND

PMID: 11117911 (View on PubMed)

Jobin G, Rodriguez-Suarez R, Betito K. Association Between Natural Killer Cell Activity and Colorectal Cancer in High-Risk Subjects Undergoing Colonoscopy. Gastroenterology. 2017 Oct;153(4):980-987. doi: 10.1053/j.gastro.2017.06.009. Epub 2017 Jun 15.

Reference Type: RESULT

PMID: 28625834 (View on PubMed)

Other Identifiers

ATG-001

Identifier Type: -

Identifier Source: org_study_id