Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 396
- 试验地点
- 6
- 主要终点
- Test performance of NK Vue (ability of NK Vue to detect CRC in those subjects in risk categories P2, P3 or P4)
研究概览
简要总结
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.
详细描述
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 for colonoscopy for one of the following reasons: suspicion of having an inflammatory bowel condition, rectal bleeding, presence of occult blood in stool, unexplained iron deficiency anemia, recent change in bowel habits, family history of CRC or adenomatous polyps or other hereditary colorectal diseases. Often, colonoscopy is not performed within the government-prescribed recommended delays, leading to waiting lists for the procedure. Analysis of NK cell activity may help identify those at risk for the presence of CRC and therefore help prioritize subjects on these waiting lists, help manage resources and help convince subjects to have a colonoscopy. Furthermore, all subjects will undergo a FIT, allowing a determination of the ability of each test alone, as well as a combination of NK Vue and FIT, to predict outcome on colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
Endoscopist will not be provided the results of either the FIT or NK Vue tests performed as part of the trial; biochemist will not be provided the results of the colonoscopy
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 40 and over who are scheduled to undergo colonoscopy at the research site and who are classified in category P2, P3 or P
- •Subjects who provide informed consent to participate in the trial
排除标准
- •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.
结局指标
主要结局
Test performance of NK Vue (ability of NK Vue to detect CRC in those subjects in risk categories P2, P3 or P4)
时间窗: NK Vue blood draw taken within 7 days of FIT stool sampling and prior to colonoscopy
Test performance of NK Vue for CRC will be assessed by ROC analysis and logistic regression, adjusting for subject baseline characteristics
次要结局
- Test performance of FIT, to be determined at different cut-offs reflective of the various Canadian provincial cut-offs.(FIT performed at home and sample brought to institution within 7 days of collection and prior to coloscopy)
- Test performance of NK Vue in combination with FIT(FIT and NK Vue performed up to 4 weeks prior to colonoscopy, with NK Vue draw within 7 days of stool sampling)