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临床试验/NCT04144751
NCT04144751已完成不适用

Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "Clinical Validation of an Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C"

Exact Sciences Corporation187 个研究点 分布在 1 个国家目标入组 23,494 人开始时间: 2019年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23,494
试验地点
187
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, 2019-01B, is to collect blood specimens for research use in the development and validation of a blood-based test for colorectal cancer (CRC).

详细描述

Subjects who consent to enroll in Exact Sciences Protocol 2019-01 BLUE-C, will be invited to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2019-01 BLUE-C, 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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject is currently enrolled in Exact Sciences Protocol 2019-01 BLUE-C.
  • 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

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (187)

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