Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 264
- 试验地点
- 5
- 主要终点
- Acceptance Criteria
研究概览
简要总结
This clinical study will demonstrate the accuracy of the chromosomal aberration and gene mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug Administration for in vitro diagnostic use within the United States of America.
The objective is to demonstrate the positive and negative percent agreement of each marker by comparing AMLProfiler results from multiple clinical participating sites with data generated using a laboratory developed bi-directional sequencing method generated at the molecular diagnostic reference lab.
The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or APL specific chromosomal aberrations (specific recurrent translocations and inversions), as well as expression of specific genetic markers in RNA extracted from bone marrow aspirates of patients with Acute Myeloid Leukemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
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
- •Subjects with a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
- •Written informed consent
排除标准
- •Subjects without a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
- •< 18 years
- •Without written informed consent
结局指标
主要结局
Acceptance Criteria
时间窗: Sample taken at initial visit with no follow up (Day 1)
The acceptance criteria based on lower level of the 95% CI of the positive or negative percent agreement for all markers.
次要结局
未报告次要终点