Evaluation of the Plasma Cell Disorders Panel on the BD FACSLyric™ Flow Cytometer

Last updated: October 26, 2023
Sponsor: Becton, Dickinson and Company
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

IUO Plasma Cell Disorders Panel

Clinical Study ID

NCT05032339
CAS-OFLYRICPP-IVDR
  • Ages > 22
  • All Genders

Study Summary

Multi-site, prospective performance study to determine equivalency between the investigational OneFlow PCD panel on the FACSLyric system versus the final clinical diagnosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Specimen collected/handled prior to enrollment in accordance with site policies andprocedures.
  2. Specimen with adequate volume (approximately 300 µL) to complete protocol tests.
  3. Specimen is leftover BM from routine flow cytometry laboratory testing for plasma celldisorders, other hematological disorders, non-hematological tumors, and otherhematological disorders (non-malignant).
  4. Specimen from a newly diagnosed or relapsed subject.
  5. Specimen is stored at room temperature, upon receipt by the site.
  6. Age of specimen (time of collection to start of first pre-wash): ≤24 hours.
  7. Specimen collected in EDTA (K2 or K3) or heparin (sodium or lithium).
  8. Specimens are from subjects irrespective of race, gender, and ethnicity.

Exclusion

Exclusion Criteria:

  1. Specimen from healthy subject.
  2. Specimen from subject <22 years old.
  3. Specimen from subject undergoing any treatment for any form of L&L.
  4. Specimen from subject with minimal residual disease (MRD) as determined by site.
  5. Visibly clotted specimen.
  6. Visibly hemolyzed specimen.
  7. Frozen specimen.
  8. Refrigerated specimen.
  9. Fixed specimen.

Study Design

Total Participants: 208
Treatment Group(s): 1
Primary Treatment: IUO Plasma Cell Disorders Panel
Phase:
Study Start date:
May 04, 2021
Estimated Completion Date:
October 25, 2023

Study 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 and accurate focus on targets. Currently, there are no general consensus panels being used; as a consequence, 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/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 panel for plasma cell disorders is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell 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, plasma cell disorders.

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.

Connect with a study center

  • Fleury Group

    São Paulo,
    Brazil

    Site Not Available

  • Champalimaud Foundation

    Lisbon,
    Portugal

    Site Not Available

  • University of Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Kantonsspital Aarau

    Aarau,
    Switzerland

    Site Not Available

  • Cambridge university hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Corepath Laboratories

    San Antonio, Texas 78229
    United States

    Site Not Available

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