NCT02066259Unknown不适用
OctavaColon Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol
Eventus Diagnostics Ltd3 个研究点 分布在 1 个国家目标入组 1,080 人开始时间: 2014年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,080
- 试验地点
- 3
- 主要终点
- Number of participants in each of the clinicaly defined groups (0,1 and 2).
研究概览
简要总结
The OctavaColon tests are qualitative plasma tests that are indicated to people above 18 years of age suspected with colon abnormality. The blood tests will provide additional information to the doctor in the course of colon cancer diagnosis for both normal population and high risk population
详细描述
The clinical objective of this study is to develop two antibody-based blood tests for additional information during colon cancer diagnosis -
- Highly specific (OctavaGold) - provides additional information to doctors during evaluation of normal population.
- Highly sensitive (OctavaSilver) - provides additional information to doctors during evaluation of high risk population.
The study will be considered successful it can achieve at least one of the following sets of performances -
- For the OctavaGold - 95% specificity with at least 50% sensitivity.
- For the OctavaSilver - 95% sensitivity with at least 50% specificity. The biological objective of this study is to find the best set of antigens, that when combined with the appropriate algorithm will support each of the above clinical objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 18 years or over. Subjects scheduled for colonoscopy or surgery
排除标准
- •Subjects less than 18 years of age
- •Previous or concurrent synchronous cancers other than previous malignancies of the colon and recovered melanoma
- •Autoimmune disorders diagnosed subjects
- •Hematological malignancies
- •Subjects under active chemotherapy treatment or chemotherapy in the past 6 months
- •Steroid treatment in the past 3 months
- •Subject undergoing immunosuppressive treatments
- •Subject with verified melanoma colon cancer
- •Subject with verified sarcoma colon cancer
结局指标
主要结局
Number of participants in each of the clinicaly defined groups (0,1 and 2).
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (3)
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