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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02291198
• Date of registration: 10/11/2014
• Prospective Registration: No
• Primary sponsor: ATGen Canada Inc
• Public title: Measurement of NK Cell Activity in Whole Blood in Subjects Being Screened for Colorectal Cancer Using Colonoscopy
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 1081
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02291198
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Gilles Jobin, MD, FRCP
• Affiliation: Maisonneuve-Rosemont Hospital

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Natural Killer Cell Cytokine Production

Intervention(s)

Device: NK Vue: NK cell activity in stimulated whole blood

Primary Outcome(s)

NK cell activity [Time Frame: Blood drawn for NK cell activity on day of colonoscopy]

Secondary ID(s)

ATG-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Maisonneuve-Rosemont Hospital