Evaluation of ClearLLab LS Screening Panel for the Diagnosis of Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 831
- 试验地点
- 4
- 主要终点
- Diagnostic accuracy: sensitivity and specificity
研究概览
简要总结
This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies.
详细描述
This study aims to evaluate the clinical accuracy of ClearLLab LS screening panel in the diagnosis of hematologic malignancies. The residual specimens, which from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematologic diseases work-up, will be tested by ClearLLab LS screening panel. ClearLLab LS screening panel is CE-IVD marked immunophenotyping reagents under the European Union (EU) regulation, and this study is aimed to validate its clinical performance in Chinese population.
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 whole blood, bone marrow, or lymph node tissue samples from subjects with hematologic tumor-related symptoms and/or signs that are clinically recommended for Flow Cytometry Immunophenotyping
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 Ethylene Diamine Tetraacetic Acid (EDTA) anticoagulant older than 24 hours from time of collection
- •Specimens and/or spent samples collected in Heparin or Acid Citrate-Dextrose (ACD) anticoagulant older than 48 hours from time of collection
- •Samples with insufficient volume to complete the protocol tests
- •Samples from subjects with known myeloid malignancies or multiple myeloma
结局指标
主要结局
Diagnostic accuracy: sensitivity and specificity
时间窗: Baseline
Diagnostic accuracy measured as sensitivity and specificity of ClearLLab LS screening panel in identifying hematological malignancies and non-malignancies compared with the clinical criteria (WHO guidelines)
次要结局
未报告次要终点