Blood Collection Sub-Study of Exact Sciences Protocol 2018-10: "An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 871
- 试验地点
- 37
- 主要终点
- Blood-based biomarkers associated with genetic and epigenetic alterations.
研究概览
简要总结
The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess new biomarkers for the detection of Colorectal Cancer (CRC).
详细描述
Subjects who consent to enroll in Exact Sciences Protocol 2018-10, will be asked to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2018-10, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is currently enrolled in Exact Sciences Protocol 2018-10
- •Subject is willing and able to provide a blood sample.
- •Subject is willing and able to sign informed consent.
排除标准
- •Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
结局指标
主要结局
Blood-based biomarkers associated with genetic and epigenetic alterations.
时间窗: Point in time blood collection (1 day) at enrollment
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk for development of colorectal cancer.
次要结局
未报告次要终点