Clinical trial · Observational
Evaluation of the BD OneFlow Acute Leukemia Panel on the BD FACSLyric Flow Cytometer
Evaluation of the BD OneFlow Acute Leukemia Panel (BD OneFlow ALOT, BCP-ALL T1, and AML T1-T4) on the BD FACSLyric Flow Cytometer Using Leftover, De-identified Specimens
NCT05035615CI-TRIAL-00079525completedClinicalTrials.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)
This study is a multi-site, prospective performance study to determine equivalency between the investigational OneFlow Acute Leukemia 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 |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IUO Acute Leukemia Panel | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Remnant/ Leftover specimens
- description
- Specimens that meet inclusion/exclusions criteria, are leftover from routine flow cytometry testing, and are from subjects having or suspected of having a hematological or non-hematological disorder.
- interventionNames
- Diagnostic Test: IUO Acute Leukemia Panel
Primary outcomes (2)
- measure
- Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis (Sensitivity Analysis)
- timeFrame
- Within 24 Hours of specimen collection
- description
- Determine equivalence between the investigational OneFlow Acute Leukemia Panel on the BD FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (lymphoid and myeloid) or Abnormal (neoplastic lymphoid or myeloid) phenotypes. Sensitivity will be calculated
- measure
- Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis (Specificity Analysis)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 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 (1 mL) to complete protocol tests. 3. Specimen is leftover PB and BM from routine flow cytometry laboratory testing for having or suspected of having acute leukemia disorders (i.e. AML, BCP-ALL, ALAL, etc.), myelodysplastic syndrome (MDS), other hematological, or non-hematological disorders. 4. Specimen from newly diagnosed or relapsed subject. 5. Only one specimen type (PB or BM) shall be enrolled per given subject. 6. Specimen is stored at room temperature, upon receipt by the site. 7. Specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium). 8. Age of specimen (BCP ALL T1: time of collection to start of first pre-wash; ALOT, AML T1-T4: time of collection to start of staining): ≤ 24 hours. 9. Specimens are from subjects irrespective of race, gender, and ethnicity Exclusion Criteria: 1. Specimen is from healthy subject. 2. Specimen from subject \<3 years of age. 3. Specimen is from subject undergoing any treatment for any form of leukemia. 4. Specimen is from subject with minimal residual disease (MRD) as determined by the site. 5. Specimen is from subject suspected of plasma cell disorders. 6. Visibly clotted specimen. 7. Visibly hemolyzed specimen. 8. Frozen specimen. 9. Refrigerated specimen. 10. Fixed specimen.
References
Publications (0)
Data not yet available
No reference posted for this study.