Status:
TERMINATED
Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy
Lead Sponsor:
ATGen Canada Inc
Conditions:
Immunity, Innate
Colorectal Cancer
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
This study will measure the activity of natural killer (NK) cells using the in vitro diagnostic device NK Vue in high risk subjects (Quebec risk categories P2, P3 and P4) scheduled for colonoscopy.
Detailed Description
In Quebec, subjects in risk category P2 are scheduled for colonoscopy due to high suspicion of cancer based on imaging, sigmoidoscopy or clinical exam. Subjects in categories P3 and P4 are scheduled f...
Eligibility Criteria
Inclusion
- Subjects aged 40 and over who are scheduled to undergo colonoscopy at the research site and who are classified in category P2, P3 or P4.
- Subjects who provide informed consent to participate in the trial
Exclusion
- Lack of understanding and/or participation due to illiteracy or inability to comprehend English or French
- Subjects in category P3 who are there due to knowledge or suspicion of an inflammatory bowel disease
- Previous history of cancer (any type) or active infection (as declared by the subject at the time of enrolment)
- Currently participating (or participated within the previous 120 days) in an investigational therapeutic study (in case of interference of the drug with the immune system)
- Subjects who underwent their colonoscopy and
- the colonoscopy preparation was judged insufficient
- the colonoscopy itself was judged insufficient or incomplete by the doctor
- the biopsy sample was lost and cancer could not be pathologically confirmed
- the colonoscopy detected an inflammatory bowel disease
- Female who is pregnant, nursing, or of child-bearing potential while not practicing effective contraceptive methods.
Key Trial Info
Start Date :
July 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2018
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT03249727
Start Date
July 5 2017
End Date
October 11 2018
Last Update
January 31 2023
Active Locations (3)
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1
CIUSSS de l'Est-de-l'île-de-Montréal, Installation Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
2
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 3J4
3
McGill University and the McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4