Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 3
- 主要终点
- Data Gathering
研究概览
简要总结
This repository is a multi-center, outcomes study designed to retrospectively collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing Caris Molecular Intelligence® (CMI) Services for the treatment of cancer. Prior to enrolling a subject, the subject's physician will have made the independent decision whether or not to utilize the drug associations provided by CMI and made clinical treatment choices as appropriate. Thus, data captured and reported provides a "real world" perspective on diagnosis, treatment, cost, and outcomes.
详细描述
This repository is a multi-center, outcomes study designed to retrospectively collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing Caris Molecular Intelligence® (CMI) Services for the treatment of cancer. Prior to enrolling a subject, the subject's physician will have made the independent decision whether or not to utilize the drug associations provided by CMI and made clinical treatment choices as appropriate. Thus, data captured and reported provides a "real world" perspective on diagnosis, treatment, cost, and outcomes.
Patients who have had CMI testing prior to the initial IRB submission date of November 11, 2016 for the respective site would be eligible to have their treatment and treatment response data entered into the study Database. All entered data would be de-identified. The patient's CMI biomarker results and treatment response data will be coupled together in order to allow the investigation of research questions concerning biomarker status and treatment response.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject' s age must be greater than or equal to 18 years and must have received CMI testing prior to the initial protocol IRB submission date of November 11, 2016.
排除标准
- •Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation.
结局指标
主要结局
Data Gathering
时间窗: 5 years per patient
Documentation of the frequency of specific clinical events in relation to diagnosis, treatments and outcomes provided
次要结局
未报告次要终点
