Evaluation of the BD OneFlow Acute Leukemia Panel on the BD FACSLyric Flow Cytometer
Completed
Conditions studied: Acute Leukemia
In brief
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.
Key facts
- Study ID
- NCT05035615
- Run by
- Becton, Dickinson and Company
- People needed
- 332
- Starts
- 2021-11-02
- Expected to finish
- 2024-07-18
- Last updated by the study team
- 2024-08-06
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
- Specimen with adequate volume (1 mL) to complete protocol tests.
- 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.
- Specimen from newly diagnosed or relapsed subject.
- Only one specimen type (PB or BM) shall be enrolled per given subject.
- Specimen is stored at room temperature, upon receipt by the site.
- Specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium).
- 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.
- Specimens are from subjects irrespective of race, gender, and ethnicity
You may not qualify if…
- Specimen is from healthy subject.
- Specimen from subject <3 years of age.
- Specimen is from subject undergoing any treatment for any form of leukemia.
- Specimen is from subject with minimal residual disease (MRD) as determined by the site.
- Specimen is from subject suspected of plasma cell disorders.
- Visibly clotted specimen.
- Visibly hemolyzed specimen.
- Frozen specimen.
- Refrigerated specimen.
- Fixed specimen.
Where it is running
- Childrens Hospital Los Angeles — Los Angeles, California, United States
- New York-Presbyterian Hospital Weill Cornell Medicine — New York, New York, United States
- University Of North Carolina — Chapel Hill, North Carolina, United States
- CorePath Laboratories — San Antonio, Texas, United States
- Fleury Group — São Paulo, Brazil
- Motol University Hospital, Childhood Leukemia Investigation — Prague, Czechia
- University of Salamanca — Salamanca, Spain
- Cambridge University — Cambridge, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.