MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Agendia
- 入组人数
- 30,000
- 试验地点
- 132
- 主要终点
- A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created.
研究概览
简要总结
The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.
详细描述
The FLEX Registry will include all patients with stage I-III breast cancer who have received MammaPrint and BluePrint testing in any clinical setting. Study arm appendices will specify treatment arm, inclusion criteria, and number of patients needed. Approximately 30,000 patients from 125+ US based institutions will be enrolled.
Treatment is at the discretion of the physician adhering to NCCN approved regimens of a recognized alternative.
Clinical data will be collected and entered online at the time points listed: patient enrollment, time of treatment, 1 year post-treatment, and 3, 5, and 10 years post diagnosis.
Objectives:
- Create a large scale, population-based registry of full genome expression data and clinical data to investigate new gene associations with prognostic and/or predictive value
- Utilize shared registry infrastructure to examine smaller groups of interest
- Generate hypotheses for targeted subset analyses and trials based on full genome data
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female)
- •Informed consent form signed on the same day or before enrollment
- •New primary lesion
排除标准
- •Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
- •Metastatic disease
- •Recurrent disease
- •Stage 0 disease
结局指标
主要结局
A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created.
时间窗: 10 years
Create a large scale registry of full genome expression data with clinical data to investigate possible new gene associations with prognostic or predictive value.
A shared registry infrastructure to examine smaller groups of interest.
时间窗: 10 years
Create a shared registry infrastructure to examine smaller groups of interest.
次要结局
- Subset analyses based on full genome data will be created.(10 years)