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临床试验/NCT01214512
NCT01214512已完成不适用

Performance Evaluation of the Micromedic CD24 Western Blot and ELISA in Vitro Diagnostic Assay

Meir Medical Center2 个研究点 分布在 1 个国家目标入组 229 人开始时间: 2011年1月最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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