NCT02291198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,081

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

November 10, 2014

Last Update Submit

August 11, 2017

Conditions

Natural Killer Cell Cytokine Production

Keywords

colorectal cancernatural killer cell activityscreeningNK cells

Outcome Measures

Primary Outcomes (1)

  • NK cell activity

    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.

    Blood drawn for NK cell activity on day of colonoscopy

Interventions

NK Vue: NK cell activity in stimulated whole bloodDEVICE

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.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (7)

  • 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.

    PMID: 24561245BACKGROUND

  • 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.

    PMID: 24223759BACKGROUND

  • 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.

    PMID: 24266014BACKGROUND

  • 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.

    PMID: 18174257BACKGROUND

  • 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.

    PMID: 16397273BACKGROUND

  • 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.

    PMID: 11117911BACKGROUND

  • 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.

    PMID: 28625834RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Gilles Jobin, MD, FRCP

    Maisonneuve-Rosemont Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 14, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2016

Study Completion

March 1, 2017

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

CA(1)