NCT01214512已完成不适用
Performance Evaluation of the Micromedic CD24 Western Blot and ELISA in Vitro Diagnostic Assay
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 2
- 主要终点
- Colonoscopy and CD24 assay correlation
研究概览
简要总结
This study is aimed to evaluate the performance of the Micromedic CD24 assay in identifying colorectal adenoma using Western blot and ELISA assays. These assays are designed to detect CD24 protein in peripheral blood leukocytes (PBL). Elevated levels of CD24 may be indicative of colorectal adenoma (inclusive of optically detectable early adenoma to late adenoma, and cancer).
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 50 years old and above
- •Subject is asymptomatic and referred for regular recommended screening colonoscopy or subject is referred due to suspicion of colon cancer, prior to beginning of any treatment (enriched population)
- •Subject signed the informed consent
排除标准
- •Subject has been previously diagnosed with any type of cancer
- •Subject has been previously diagnosed with a colorectal abnormality such as colorectal adenoma, hyperplastic polyp or carcinoma
- •Blood sample was not collected on the day of colonoscopy and prior to colonoscopy
- •Subject has first degree family history of colorectal cancer
- •Subject has active infection or inflammation as determined clinically at screening
- •Subject is currently taking medications related to the previous exclusion criteria
- •Subject has participated in, or is participating in, any investigational drug or device study within 30 days prior the date of colonoscopy and any additional study required test
- •Pregnant or lactating woman
结局指标
主要结局
Colonoscopy and CD24 assay correlation
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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