跳至主要内容
临床试验/NCT02900248
NCT02900248终止不适用

Patients Diagnosed With Advanced Malignancy or Myelodysplasia, Tested by Standardized Sequencing, and Treated by Physician-Determined Care Plan: A CureOne Observational Registry (N1)

CureOne1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
23
试验地点
1
主要终点
Best Overall Response

研究概览

简要总结

Registry participants with advanced malignancy or myelodysplasia will have a sample of their tumor or tissue analysed for genetic alterations using next generation sequencing (NGS) performed in a lab that has been certified to meet a high quality standard. Treatments and outcomes will be reported to the registry to allow further understanding of how genetic differences can lead to better diagnosis and treatments.

详细描述

Every malignancy or myelodysplasia is different on a molecular (genetic) level even in patients with the same diagnosis. These differences often give prognostic information, determine what types of treatments are available for a patient, as well as determine outcomes. In this registry, the method of identifying the genetic difference of the disease (using Next Generation Sequencing or NGS) is standardized, the treatments received by a patient, and the outcome of these treatments are entered into a database where all identifying information is removed.

Payers (insurance companies) or others will generally pay for the testing, laboratories will report the genetic information, physicians and eventually patients will report treatments and outcomes. This information will then be reviewed frequently and analyzed to find better methods to improve the testing or treatments of disease.

It is expected that dozens of other trials or registries will eventually be available for participants.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Best Overall Response

时间窗: 5 years

Best overall response by line of therapy and biomarker

Time to Treatment Progression

时间窗: 5 years

Physician-determined Time to Treatment Progression by line of therapy and method of determining progression (worsening of disease, new lesions, clinical decline, and/or other).

次要结局

  • Overall Survival(5 years)
  • To determine rate of enrollment into existing and future therapeutic clinical trials.(5 years)
  • Establish stable estimates of biomarker prevalence in patients with advanced malignancies in a large population.(5 years)

研究者

发起方
CureOne
申办方类型
Other
责任方
Sponsor

研究点 (1)

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