CLEAR Registry Study: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-UM Multigene Assay Results and Associated Patient Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 主要终点
- documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay
研究概览
简要总结
Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every year. Nearly half of these experience spread of their cancer outside the eye. The DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or high risk (class 2) of spreading. This study is being done to collect information about how physicians are using the DecisionDx-UM results to design individual treatment plans. It will also track outcomes or the uveal melanoma population that received DecisionDx-UM testing.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of Uveal Melanoma
- •Patients whose physician deems them appropriate for DecisionDx-UM testing
- •Patients reasonably able to follow up with enrolling physician at regular intervals for assessment of outcome data
排除标准
- •Patients with any other form of cancer
结局指标
主要结局
documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay
时间窗: Approximately 3-6 weeks after biopsy of uveal tumor
Physician treatment plan with regards to surveillance regimen as well as treatment referral pattern
Time to metastasis
时间窗: Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals
次要结局
- changes in health care costs(Patients followed for up to 10 years at 6 month intervals)