Clinical trial · Observational
Evaluation of the Plasma Cell Disorders Panel on the BD FACSLyric™ Flow Cytometer
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
NCT05032339CI-TRIAL-00070886completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multi-site, prospective performance study to determine equivalency between the investigational OneFlow PCD panel on the FACSLyric system versus the final clinical diagnosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Plasma Cell Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IUO Plasma Cell Disorders Panel | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Remnant/ Leftover specimens
- description
- Specimens that meet inclusion/exclusions criteria and are leftover from routine flow cytometry testing for plasma cell disorders
- interventionNames
- Diagnostic Test: IUO Plasma Cell Disorders Panel
Primary outcomes (1)
- measure
- Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis
- timeFrame
- Age of specimen for Peripheral Blood (PB) andBone Marrow (BM) (time of collection to start of first pre-wash): ≤ 24 hours.
- description
- 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 .
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.