NCT03421626已完成不适用
Clinical Evaluation of the Xpert BCR-ABL Ultra Assay on the GeneXpert Instrument Systems
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cepheid
- 入组人数
- 266
- 试验地点
- 7
- 主要终点
- Method comparison to an on-market molecular diagnostic assay
研究概览
简要总结
The objective of this study is to establish the performance of an assay that detects mRNA transcript levels in patients diagnosed with CML. The study is conducted at locations within the United States. Testing is performed on peripheral blood specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •prospective specimens:
- •Patient is at least 18 years of age
- •Patient has provided documented informed consent as required by the reviewing IRB. Experimental Bill of Rights will also be documented for all subjects enrolled in applicable states.
- •Patient has been diagnosed with CML.
- •Patient consents to provide at least 12 mL of peripheral blood for study purposes
- •frozen specimens:
- •Specimen is from a subject diagnosed with CML
- •Specimen meets the manufacturer's criteria to support testing by both diagnostic assays
排除标准
- •prospective specimens:
- •Patient is considered to be of insufficient health to supply the required volume of peripheral blood by his/her health care provider
- •Patient has been previously enrolled
- •frozen specimens: • Specimen previously enrolled
结局指标
主要结局
Method comparison to an on-market molecular diagnostic assay
时间窗: Baseline = testing upon enrollment
Comparison of Xpert to an on-market test for the quantitation of BCR-ABL
次要结局
未报告次要终点
研究者
研究点 (7)
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