Hematologic Diseases, Hematologic Malignancy, Hematologic Neoplasms
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTFlow Cytometry
Immunophenotyping of residual clinical samples tested with ClearLLab LS screening panel on a specified Flow Cytometry
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
The First Affiliated Hospital of Soochow University
The First Affiliated Hospital with Nanjing Medical University
Tongji Hospital
Beckman Coulter, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy: sensitivity and specificity | 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) |
Countries
China
Outcome results
None listed