Evaluation of the Plasma Cell Disorders Panel on the BD FACSLyric™ Flow Cytometer (NCT05032339) | Clinical Trial Compass
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 range
22 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.