Natural Killer Cell Cytokine ProductionNCT02291198
Measurement of NK Cell Activity in Whole Blood in Subjects Being Screened for Colorectal Cancer Using Colonoscopy
A study testing NK Vue: NK cell activity in stimulated whole blood in people with Natural Killer Cell Cytokine Production, run by ATGen Canada Inc at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Natural Killer Cell Cytokine Production
- What is being tested?
- NK Vue: NK cell activity in stimulated whole blood
- Type of treatment
- Medical device
- How many people
- 1,081 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- NK Vue: NK cell activity in stimulated whole blood
- Keywords
- colorectal cancer, natural killer cell activity, screening, NK cells
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Blood drawn for NK cell activity on day of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Natural Killer Cell Cytokine ProductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- ATGen Canada Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maisonneuve-Rosemont Hospital
- Responsible party
- Sponsor
- Investigators
- Gilles Jobin, MD, FRCP, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291198
- Sponsor's protocol ID
- ATG-001
- Status last verified
- Aug 2017
- First submitted
- 10 Nov 2014
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24561245Koo 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.
PubMed 24223759Kim 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.
PubMed 24266014Furue 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.
PubMed 18174257Hayashi 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.
PubMed 16397273Imai 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.
PubMed 11117911Jobin 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.
PubMed 28625834
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02291198
- Acronym / sponsor ID
- ATG-001
- Conditions
- Natural Killer Cell Cytokine Production
- Keywords
- colorectal cancer, natural killer cell activity, screening, NK cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,081 participants (actual)
- Lead sponsor
- ATGen Canada IncIndustry (pharma, biotech, devices)
- Collaborators
- Maisonneuve-Rosemont Hospital
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK Vue: NK cell activity in stimulated whole bloodOne 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. | Device | – |
Primary outcome
NK cell activity
Time frame: Blood drawn for NK cell activity on day of colonoscopy
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Background: PubMed 24561245Lee 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.
- Background: PubMed 24223759Koo 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.
- Background: PubMed 24266014Kim 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.
- Background: PubMed 18174257Furue 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.
- Background: PubMed 16397273Hayashi 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.
- Background: PubMed 11117911Imai 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 publication: PubMed 28625834Jobin 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Jobin, MD, FRCP principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NK Vue: NK cell activity in stimulated whole blood in people with Natural Killer Cell Cytokine Production, run by ATGen Canada Inc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NK cell activity (time frame: Blood drawn for NK cell activity on day of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291198, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.