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Clinical Trial Summary

Multi-site, prospective performance study to determine equivalency between the investigational CLPD Limited Panel on the FACSLyric system versus the final clinical diagnosis.


Clinical Trial Description

Hematology laboratories rely on flow cytometry technology (in addition to classic hematological methods) to aid in screening, diagnosing, and monitoring patients with hematological disorders. High speed and broad applicability of flow cytometry allows for the diagnosis. Currently, there are no consensus panels being used; consequently, the leukemia & lymphoma (L&L) testing remains a single-vial antibody being used with various in-house laboratory developed tests (LDTs) being used to test patient specimens. Furthermore, the analysis of flow cytometer generated data is not standardized and requires a high level of expertise and training for interpretation of complex data. Therefore, optimized and standardized immunostaining protocols for the diagnosis, classification, and prognostic sub-classification of hematological malignancies are needed. This investigational reagent panel for chronic lymphoproliferative diseases (CLPD) is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of mature lymphocyte populations on the BD FACSLyric flow cytometer . These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, B-cell CLPD, T-cell CLPD, and NK-cell CLPD. Enrollment will occur at up to 8 investigational sites . Data will be acquired from Eligible remnant/leftover specimens on the BD FACSLyric flow cytometer and evaluated by site personnel and expert analysts . The final diagnosis and the affected cell population will be determined by site standard of care . Analysis of data will evaluate identification of normal vs abnormal cell population of the expert & site analysts as compared to the final diagnosis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05032313
Study type Observational
Source Becton, Dickinson and Company
Contact Kimberly Dean
Phone 669-254-0972
Email [email protected]
Status Recruiting
Phase
Start date April 26, 2021
Completion date March 21, 2022