CompletedNot Applicable

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

United States, Portugal, Spain208 participantsStarted 2021-05-04

Plain-language summary

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

Who can participate

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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.

Trial details

NCT IDNCT05032339

SponsorBecton, Dickinson and Company

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-10-25

View on ClinicalTrials.gov More Plasma Cell Disorder trials