跳至主要内容
临床试验/NCT02121899
NCT02121899终止不适用

LUNG CAncerREgistry: An Open Registry to Measure the Impact of Adding RNA Expression Testing (myPlan Lung Cancer) on Treatment Decisions and to Assess Disease-free Survival With Long-term Follow-up in Newly Diagnosed Early Stage Lung Adenocarcinoma Patients (LUNG CARE Registry)

Myriad Genetic Laboratories, Inc.0 个研究点目标入组 44 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
44
主要终点
Percentage change from Pre-Test treatment recommendation to Post-test treatment initiated

研究概览

简要总结

This registry is intended to measure the effect of myPlan Lung Cancer™ test has on influencing treatment decisions of Oncologists 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 Oncologists (ONC006).

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

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
  • Exclusion Criteria
  • Previous myPlan Lung Cancer test performed
  • 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

排除标准

  • 未提供

结局指标

主要结局

Percentage change from Pre-Test treatment recommendation to Post-test treatment initiated

时间窗: 3 months

The percentage change from the recorded Pre-Test treatment recommendation by the oncologist versus the Post-Test treatment initiated.

次要结局

  • Assessment of disease free survival from resection to relapse or death(3 years)

研究者

申办方类型
Industry
责任方
Sponsor

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