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

Completed

• Conditions: Plasma Cell Disorder
• Interventions: Diagnostic Test: IUO Plasma Cell Disorders Panel

• Registration Number: NCT05032339
• Lead Sponsor: Becton, Dickinson and Company

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-05-04
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-02
• Status Verified: 2023-10
• Primary Completion: 2023-10-25
• Study Completion: 2023-10-25
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

1. Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
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 cell disorders, other hematological disorders, non-hematological tumors, and other hematological 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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remnant/ Leftover specimens	IUO Plasma Cell Disorders Panel	Specimens that meet inclusion/exclusions criteria and are leftover from routine flow cytometry testing for plasma cell disorders

Primary Outcome Measures

Name	Time	Method
Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis	Age of specimen for Peripheral Blood (PB) andBone Marrow (BM) (time of collection to start of first pre-wash): ≤ 24 hours.	Determine equivalence between the investigational OneFlow PCD Panel on FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for normal polyclonal plasma cells or abnormal plasma cells using leftover, hematologically abnormal specimens.; Sensitivity and specificity will be calculated .

Trial Locations

Locations (5)

Cambridge university hospital; 🇬🇧 Cambridge, United Kingdom

Corepath Laboratories; 🇺🇸 San Antonio, Texas, United States

University of Salamanca; 🇪🇸 Salamanca, Spain

Champalimaud Foundation; 🇵🇹 Lisbon, Portugal

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland