Measurement of NK Cell Activity in Whole Blood in Subjects Being Screened for Colorectal Cancer Using Colonoscopy
Primary Purpose
Natural Killer Cell Cytokine Production
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
NK Vue: NK cell activity in stimulated whole blood
Sponsored by
About this trial
This is an interventional screening trial for Natural Killer Cell Cytokine Production focused on measuring colorectal cancer, natural killer cell activity, screening, NK cells
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.
Sites / Locations
- Hopital Maisonneuve-Rosemont
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02291198
First Posted
November 10, 2014
Last Updated
August 11, 2017
Sponsor
ATGen Canada Inc
Collaborators
Maisonneuve-Rosemont Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02291198
Brief Title
Measurement of NK Cell Activity in Whole Blood in Subjects Being Screened for Colorectal Cancer Using Colonoscopy
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ATGen Canada Inc
Collaborators
Maisonneuve-Rosemont Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Natural Killer Cell Cytokine Production
Keywords
colorectal cancer, natural killer cell activity, screening, NK cells
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1081 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
NK Vue: NK cell activity in stimulated whole blood
Intervention Description
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 Outcome Measure Information:
Title
NK cell activity
Description
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.
Time Frame
Blood drawn for NK cell activity on day of colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Jobin, MD, FRCP
Organizational Affiliation
Maisonneuve-Rosemont Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24561245
Citation
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.
Results Reference
background
PubMed Identifier
24223759
Citation
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.
Results Reference
background
PubMed Identifier
24266014
Citation
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.
Results Reference
background
PubMed Identifier
18174257
Citation
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.
Results Reference
background
PubMed Identifier
16397273
Citation
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. Erratum In: Cancer Res. 2006 Jun 1;66(11):5976.
Results Reference
background
PubMed Identifier
11117911
Citation
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.
Results Reference
background
PubMed Identifier
28625834
Citation
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.
Results Reference
result
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Measurement of NK Cell Activity in Whole Blood in Subjects Being Screened for Colorectal Cancer Using Colonoscopy
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