Evaluation of the Chronic Lymphoproliferative Diseases Limited Panel on the BD FACSLyric™ Flow Cytometer

Completed

Conditions studied: Chronic Lymphoproliferative Diseases (CLPD)

In brief

Multi-site, prospective performance study to determine equivalency between the investigational CLPD Limited Panel on the FACSLyric system versus the final clinical diagnosis.

Key facts

Study ID

NCT05032313

Run by

Becton, Dickinson and Company

People needed

371

Starts

2021-04-26

Expected to finish

2023-12-29

Last updated by the study team

2024-02-28

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 PB, BM, or LN from routine flow cytometry laboratory testing for chronic lymphoproliferative disorders, other hematological disorders, non-hematological tumors (e.g., solid tumors), or other non-hematological disorders (non-malignant).
• Specimen from newly diagnosed or relapsed subject.
• Only one type of specimen, either PB, BM, or LN shall be enrolled per given subject.
• Specimen is stored at room temperature, upon receipt by the site.
• PB and BM specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium).
• LN specimens collected in PBS, culture media (e.g., RPMI-1640), saline, or saline wrapped gauze at the discretion of the Investigator.
• Age of specimen for PB and BM (time of collection to start of first pre-wash): ≤ 24 hours. (Note: No Age of specimen claim is being made for LN)
• Specimens are from subjects irrespective of race, gender, and ethnicity.

You may not qualify if…

• Specimen is from healthy subject.
• Specimen is from subject undergoing any treatment for any form of L\&L.
• Specimen from subject <22 years of age.
• Specimen is from subject with minimal residual disease (MRD) as determined by the site.
• Specimen is from subject suspected of acute leukemia (e.g., T-ALL, BCP-ALL, AML) or myeloid dysplastic syndrome (MDS).
• Visibly clotted specimen.
• Visibly hemolyzed specimen.
• Frozen specimen.
• Refrigerated specimen.
• Fixed specimen.

Where it is running

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

Full record on ClinicalTrials.gov

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