Clinical trial · Interventional
Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy
NCT03249727CI-TRIAL-00063568ANKA-HRterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruiting issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Immunity, Innate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IVDD for NK cell activity in whole blood | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Test performance of NK Vue (ability of NK Vue to detect CRC in those subjects in risk categories P2, P3 or P4)
- timeFrame
- NK Vue blood draw taken within 7 days of FIT stool sampling and prior to colonoscopy
- description
- Test performance of NK Vue for CRC will be assessed by ROC analysis and logistic regression, adjusting for subject baseline characteristics
Secondary outcomes (2)
- measure
- Test performance of FIT, to be determined at different cut-offs reflective of the various Canadian provincial cut-offs.
- timeFrame
- FIT performed at home and sample brought to institution within 7 days of collection and prior to coloscopy
- description
- 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.
- measure
- Test performance of NK Vue in combination with FIT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDJobin 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. PMID 28625834