Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 11
- 主要终点
- Effecting Change
研究概览
简要总结
This repository is a multi-center, outcomes study designed to 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.
详细描述
This repository is a multi-center, outcomes study designed to 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.
Prospective data will be obtained only from consented patients or patients who have died or have been lost to follow-up. Lost to follow-up is defined as a subject who has not returned for continued care or evaluation (e.g., disability, relocation or unresponsiveness). Site coordinators are required attempt to contact the subject 3 times before deeming them lost to follow up. Data collection and the protection of privacy are discussed in the Methods section below.
In addition to treatment and response data, initial diagnosis and staging results will be recorded as well as any recurrence information. As the investigators are capturing the subject's cancer treatment as a whole, results from pertinent cancer-related tests performed by outside entities for eligible subjects will need to be collected by the site coordinator and maintained at the site accordingly for reporting and monitoring purposes.
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
- 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
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
Effecting Change
时间窗: within 5 years
Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment.
Cultivate a repository for assay development
时间窗: within 5 years
Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
Evaluate the frequency of specific clinical events
时间窗: within 5 years
Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed.
Performing retrospective research
时间窗: within 5 years
Performing retrospective research including clinical presentation, treatment and outcomes. This eligible cohort includes select subjects who have already undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management.
Provide information access that is vital to research collaborators
时间窗: within 5 years
Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms.
次要结局
未报告次要终点