NCT02121925终止不适用
LUNG CAncerREgistry: An Open Registry to Measure the Impact of Adding RNA Expression Testing (myPlan Lung Cancer) on Referral Decisions and to Assess Disease-free Survival With Long-term Follow-up in Newly Diagnosed Early Stage Lung Adenocarcinoma Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 227
- 主要终点
- Percentage change from Pre-Test to Post-Test referral
研究概览
简要总结
This registry is intended to measure the effect of myPlan Lung Cancer™ test has on treatment decisions of Surgeons when added to standard clinical-pathological parameters in patients with early stage NSCLC.The sponsor is conducting two parallel registries, with one directed at Surgeons (ONC003) and the other at Oncologists (ONC006).This registry is specific to Surgeons (ONC003). Outcomes measures on lung cancer relapse and death from any cause will be collected.
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
- •Diagnosis of early stage non-small cell lung adenocarcinoma
- •Sub-population staging (IA, IB or IIA) as judged by the standard of practice at the investigational site
- •Resection of tumor within previous 2 months of enrollment
- •ECOG performance of 0-2
- •A minimum life expectancy of six months
排除标准
- •Pre-operative radiation or chemotherapy for NSCLC
- •Post-operative radiation or chemotherapy for NSCLC
- •Enrollment in a separate clinical trial restricting treatment options
- •Unable to provide informed consent
结局指标
主要结局
Percentage change from Pre-Test to Post-Test referral
时间窗: 3 months
The percentage change from the recorded PRE-TEST referral by surgeon versus the POST-TEST referral following results of myPlan Lung Cancer testing
次要结局
- Assessment of disease free survival from resection to relapse or death(3 years)
- Percentage change from the Pre-test referral to the 60-day Post-Test referral(2 months)
- Percentage of patients at 60 days post test receiving treatment(2 months)
- Percentage change from Pre-Test to Post-Test chest surveillance plan(3 months)
研究者
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