An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results and Associated Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Adjusted surveillance regimen
研究概览
简要总结
The EXPAND Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed as part of their clinical care. Data will be collected through review of medical records from clinical visits with physician.
The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.
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 diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration
- •Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data.
- •16 Years and older
排除标准
- •Less than 16 Years of age
结局指标
主要结局
Adjusted surveillance regimen
时间窗: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter
* Relaxed surveillance for the low risk group; * Increased vigilance for early detection in the high risk group.
次要结局
- Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.(Upon receipt DecisionDx-Melanoma results)