Observational Study of Sub-populations From "A Longitudinal Study of Cologuard in an Average Risk Population Assessing a Three Year Test Interval"/Protocol 2014-01 Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 20
- 主要终点
- The number of subjects with discordant results that can be attributed to intercurrent disease
研究概览
简要总结
The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.
详细描述
Subjects who consented to enroll in Exact Sciences Protocol 2014-01, that fit one of the following sub-populations, will be asked to participate in the sub-study. Population 1 includes those whose Cologuard T0 result was positive and colonoscopy result was negative. Population 2 includes those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol. Population 3 includes those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. Population 4 includes those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. Subjects that enrolled in the Exact Sciences Protocol 2014-01, who provided written informed consent to participate in this sub-study, will asked to complete the Follow-Up Questionnaire during a phone interview.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject falls into one of the 4 sub-populations
- •Willing to provide informed consent
排除标准
- •Investigator/sponsor decision
- •Subject withdrew consent
结局指标
主要结局
The number of subjects with discordant results that can be attributed to intercurrent disease
时间窗: 3 years after positive Cologuard result
A medical chart review and phone interview will be conducted for each subject. The Follow-Up Questionnaire will be completed during the phone interview.
次要结局
未报告次要终点