POA Prospective Repository
关键词
抽象
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.
日期
最后验证: | 12/31/2019 |
首次提交: | 10/12/2017 |
提交的预估入学人数: | 10/25/2017 |
首次发布: | 10/29/2017 |
上次提交的更新: | 01/22/2020 |
最近更新发布: | 01/26/2020 |
实际学习开始日期: | 06/06/2017 |
预计主要完成日期: | 12/31/2022 |
预计完成日期: | 12/31/2022 |
状况或疾病
干预/治疗
Diagnostic Test: MI Profiling
相
手臂组
臂 | 干预/治疗 |
---|---|
MI Profiling Subjects must have undergone Caris MI Profiling in order to be eligible for the study. No required intervention is dictated by the protocol. | Diagnostic Test: MI Profiling Customized comprehensive biomarker testing |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 没有 |
标准 | Inclusion Criteria: - Subject's age must be greater than or equal to 18 years and must have received CMI testing Exclusion Criteria: - Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation. |
结果
主要结果指标
1. Effecting Change [within 5 years]
2. Performing retrospective research [within 5 years]
3. Evaluate the frequency of specific clinical events [within 5 years]
4. Provide information access that is vital to research collaborators [within 5 years]
5. Cultivate a repository for assay development [within 5 years]