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| Name | Class |
|---|---|
| Institute of Hematology & Blood Diseases Hospital, China | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flow Cytometry | Diagnostic Test | Immunophenotyping of residual clinical samples tested with ClearLLab LS screening panel on a specified Flow Cytometry |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy: sensitivity and specificity | 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) | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects of any ethnicity, age and racial background will be included
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| Name | Affiliation | Role |
|---|---|---|
| China Clinical Affaris | Beckman Coulter, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | China | |||
| The First Affiliated Hospital of Nanjing Medical University |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005434 | Flow Cytometry |
| ID | Term |
|---|---|
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Tongji Hospital | OTHER |
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| Nanjing |
| Jiangsu |
| China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Tianjin | China |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |