Open Label, Prospective, Cross-Sectional Clinical Performance Study of the in Vitro Diagnostic Device NK VueTM: Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- The ability of NK cell activity to predict prostate cancer (yes/no) on biopsy
研究概览
简要总结
This study will look at measuring the activity of natural killer (NK) cells using the in vitro diagnostic device NK Vue in subjects being screened for prostate cancer using prostate biopsy.
详细描述
The NK Vue diagnostic test for natural killer cell activity uses the principle of stimulation of whole blood with a proprietary cytokine followed by the quantitative detection of interferon-gamma using an immunoassay. NK Vue is intended to be used for the monitoring of the immune status of individuals. Measurement of NK cell activity could be a useful tool for assessing changes in immunosurveillance in patients with conditions or diseases where NK cell activity has been shown to be affected.
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
NK cell activity not provided to investigator prior to biopsy; results of biopsy not provided to biochemistry lab
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged ≥ 18 years old
- •Able to read and sign an approved informed consent form
- •Soon to be undergoing a needle prostate biopsy for suspected prostate cancer; patients with a history of prior biopsy are not excluded provided the biopsy was negative
- •All prior and current recorded PSA levels are < 11 ng/mL (minimum of 2 values must be available)
- •Digital Rectal Exam performed or scheduled to be performed prior to biopsy
排除标准
- •Any other established malignancy with the exception of basal cell carcinoma
- •At time of blood collection, an active infection (eg bacterial, viral etc.) as declared by the patient
- •Chronic inflammatory condition requiring anti-inflammatory treatment such as rheumatoid arthritis, Crohn's or ulcerative colitis, Lupus or any connective tissue condition which, in the opinion of the investigator, might affect the immune response
- •Presently taking any of the following classes of medications on a regular basis:
- •5-alpha reductase inhibitors
- •Anti-inflammatories, with the exception of low dose (81 mg) acetylsalicylic acid
- •Anti-androgens
- •Testosterone replacement therapy
结局指标
主要结局
The ability of NK cell activity to predict prostate cancer (yes/no) on biopsy
时间窗: NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
Test performance of NK Vue will be assessed by logistic regression, both unadjusted and adjusted for the effects of at least PSA, age, digital rectal examination, and family history
次要结局
- The ability of NK cell activity to predict tumor grade (Gleason 2-6 vs. no cancer; Gleason 7-10 vs. no cancer)(NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment)
- Test performance metrics of NK Vue and PSA (each alone)(NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment)
- Impact of combination of NK Vue and PSA on the test performance of PSA(NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment)