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

Plasma Cell Disorder Clinical Trial

Official title:

Evaluation of the Plasma Cell Disorders Panel (BD OneFlow™ PCST and BD OneFlow™ PCD) on the BD FACSLyric™ Flow Cytometer Using Leftover, De-identified Specimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032339
• Other study ID #: CAS-OFLYRICPP-IVDR
• Status: Completed
• Start date: May 4, 2021
• Est. completion date: October 25, 2023

Study information

• Verified date: October 2023
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: October 25, 2023
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Paraproteinemias
• Plasma Cell Disorder

Intervention

Diagnostic Test:
• IUO Plasma Cell Disorders Panel
This Investigational Panel , comprised of 2 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, plasma cell disorders.

Locations

Country	Name	City	State
Portugal	Champalimaud Foundation	Lisbon
Spain	University of Salamanca	Salamanca
Switzerland	Kantonsspital Aarau	Aarau
United Kingdom	Cambridge university hospital	Cambridge
United States	Corepath Laboratories	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Countries where clinical trial is conducted

United States,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis	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 .	Age of specimen for Peripheral Blood (PB) andBone Marrow (BM) (time of collection to start of first pre-wash): = 24 hours.