Evaluation of ClearLLab Leukemia and Lymphoma Panels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 482
- 试验地点
- 4
- 主要终点
- Hematologically Malignant or Non-Malignant
研究概览
简要总结
Multi-center study of specimens from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematological diseases work-up.
详细描述
Multi-center study of specimens from subjects presenting for flow cytometry immunophenotyping as part of their standard of care for hematological diseases work-up. Residual specimens will be tested using the ClearLLab Panels to determine the presence or absence of an abnormal phenotype and compare results to clinical impression (hematological malignancy or non-malignancy).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residual samples from patients with hematological abnormalities being evaluated by Flow Cytometry for the presence or absence of an abnormal population associated with a hematological malignancy. All subjects of any ethnicity, age and racial background will be included.
排除标准
- •Specimens and/or spent samples that are visibly hemolyzed
- •Specimens and/or spent samples that are visibly clotted
- •Specimens and/or spent samples collected in K2EDTA anticoagulant older than 24 hours from time of collection
- •Specimens and/or spent samples collected in Heparin or ACD anticoagulant older than 48 hours from time of collection
- •Samples with insufficient volume to complete the protocol tests
结局指标
主要结局
Hematologically Malignant or Non-Malignant
时间窗: Residual samples must be tested within 24 hours of collection in K2EDTA or within 48 hours of collection in Heparin or ACD anticoagulants
Presence or absence of an abnormal phenotype detected using the ClearLLab Panels vs. the clinical outcome of "Hematologically Malignant" or "Hematologically Non-Malignant" from the same subject
次要结局
未报告次要终点