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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flow Cytometry | Diagnostic Test | Immunophenotyping of residual clinical samples tested with ClearLLab diagnostic reagent on a specified Flow Cytometer |
| Measure | Description | Time Frame |
|---|---|---|
| Hematologically Malignant or Non-Malignant | 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 | Residual samples must be tested within 24 hours of collection in K2EDTA or within 48 hours of collection in Heparin or ACD anticoagulants |
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Inclusion Criteria:
Exclusion Criteria:
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Specimens from new cases or follow up patients suspected of having a hematological malignancy and present with symptoms based on Bethesda guidelines.
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Padurean, MD | NeoGenomics Laboratories, Inc. | Principal Investigator |
| Mike Keeney | London Health Sciences Center | Principal Investigator |
| Joanne Luider | Calgary Laboratory Services | Principal Investigator |
| Wolfgang Kern | Munich Leukemia Laboratory | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeoGenomics Laboratories, Inc. | Fort Myers | Florida | 33913 | United States | ||
| Calgary Laboratory Services |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| 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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| Calgary |
| Alberta |
| T2N 2T9 |
| Canada |
| London Health Sciences Center | London | Ontario | N6A 5W9 | Canada |
| Munich Leukemia Laboratory | Munich | 81377 | Germany |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |