Colorectal Cancer Clinical Trial
— ANKA-HROfficial title:
Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy
NCT number | NCT03249727 |
Other study ID # | ANKA-HR |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 5, 2017 |
Est. completion date | October 11, 2018 |
Verified date | January 2023 |
Source | ATGen Canada Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 396 |
Est. completion date | October 11, 2018 |
Est. primary completion date | October 11, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: 1. 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. 2. Subjects who provide informed consent to participate in the trial Exclusion Criteria: 1. Lack of understanding and/or participation due to illiteracy or inability to comprehend English or French 2. Subjects in category P3 who are there due to knowledge or suspicion of an inflammatory bowel disease 3. Previous history of cancer (any type) or active infection (as declared by the subject at the time of enrolment) 4. 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) 5. Subjects who underwent their colonoscopy and 1. the colonoscopy preparation was judged insufficient 2. the colonoscopy itself was judged insufficient or incomplete by the doctor 3. the biopsy sample was lost and cancer could not be pathologically confirmed 4. the colonoscopy detected an inflammatory bowel disease 6. Female who is pregnant, nursing, or of child-bearing potential while not practicing effective contraceptive methods. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l'Université de Montréal | Montreal | Quebec |
Canada | CIUSSS de l'Est-de-l'île-de-Montréal, Installation Hôpital Maisonneuve-Rosemont | Montreal | Quebec |
Canada | McGill University and the McGill University Health Centre | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
ATGen Canada Inc |
Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Test performance of NK Vue (ability of NK Vue to detect CRC in those subjects in risk categories P2, P3 or P4) | Test performance of NK Vue for CRC will be assessed by ROC analysis and logistic regression, adjusting for subject baseline characteristics | NK Vue blood draw taken within 7 days of FIT stool sampling and prior to colonoscopy | |
Secondary | Test performance of FIT, to be determined at different cut-offs reflective of the various Canadian provincial cut-offs. | Test performance of FIT for CRC, using different cut-offs (=50 ng/mL, = 75 ng/mL, = 100 ng/mL and = 175 ng/mL), will be assessed by calculating the RR and by using ROC analyses at the different cut-offs. | FIT performed at home and sample brought to institution within 7 days of collection and prior to coloscopy | |
Secondary | Test performance of NK Vue in combination with FIT | Test performance of the combination of FIT at the different cut-offs (=50 ng/mL, = 75 ng/mL, = 100 ng/mL and = 175 ng/mL) and NK Vue (cut-off of <200 pg/mL), for CRC, will be assessed by calculating the RR and by using ROC analyses. Similar analyses will be done with subjects having either a positive FIT (at different cut-offs) or a NK Vue of <200 pg/mL | FIT and NK Vue performed up to 4 weeks prior to colonoscopy, with NK Vue draw within 7 days of stool sampling |
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