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

Completed

Conditions studied: Plasma Cell Disorder

In brief

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

Key facts

Study ID

NCT05032339

Run by

Becton, Dickinson and Company

People needed

208

Starts

2021-05-04

Expected to finish

2023-10-25

Last updated by the study team

2023-10-30

Who can join

Age: 22 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 (approximately 300 µL) to complete protocol tests.
• 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).
• Specimen from a newly diagnosed or relapsed subject.
• Specimen is stored at room temperature, upon receipt by the site.
• Age of specimen (time of collection to start of first pre-wash): ≤24 hours.
• Specimen collected in EDTA (K2 or K3) or heparin (sodium or lithium).
• Specimens are from subjects irrespective of race, gender, and ethnicity.

You may not qualify if…

• Specimen from healthy subject.
• Specimen from subject <22 years old.
• Specimen from subject undergoing any treatment for any form of L\&L.
• Specimen from subject with minimal residual disease (MRD) as determined by site.
• Visibly clotted specimen.
• Visibly hemolyzed specimen.
• Frozen specimen.
• Refrigerated specimen.
• Fixed specimen.

Where it is running

• University of Salamanca — Salamanca, Spain
• Kantonsspital Aarau — Aarau, Switzerland
• Corepath Laboratories — San Antonio, Texas, United States
• Champalimaud Foundation — Lisbon, Portugal
• Cambridge university hospital — 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.