Plasma Cell DisorderNCT05032339
Evaluation of the Plasma Cell Disorders Panel on the BD FACSLyric™ Flow Cytometer
An observational study of Plasma Cell Disorder, run by Becton, Dickinson and Company at 5 sites in 5 countries.
Trial summary
Multi-site, prospective performance study to determine equivalency between the investigational OneFlow PCD panel on the FACSLyric system versus the final clinical diagnosis. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Plasma Cell Disorder
- What is being tested?
- IUO Plasma Cell Disorders Panel
- How many people
- 208 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 4 May 2021to 25 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A minimum of 150 remnant/leftover bone marrow specimens from routine flow cytometry laboratory testing for plasma cell disorders, other hematological disorders, non-hematological tumors, and other hematological disorders (non-malignant). Specimens from healthy subjects will be excluded. At least 75 specimens must have abnormal plasma cells, at least 75 must have normal polyclonal plasma cells. Specimens are from subjects irrespective of race, gender, and ethnicity. Subjects above 22 years of age
Who may be able to join
- 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.
Who cannot join
- 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.
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- Frozen specimen.
- Refrigerated specimen.
- Fixed specimen.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Evaluation of the Plasma Cell Disorders Panel (BD OneFlow™ PCST and BD OneFlow™ PCD) on the BD FACSLyric™ Flow Cytometer Using Leftover, De-identified Specimens
Multi-site, prospective performance study to determine equivalency between the investigational OneFlow PCD panel on the FACSLyric system versus the final clinical diagnosis.
Read the detailed description
Hematology laboratories rely on flow cytometry technology (in addition to classic hematological methods) to aid in screening, diagnosing, and monitoring patients with hematological disorders. High speed and broad applicability of flow cytometry allows for the diagnosis and accurate focus on targets. Currently, there are no general consensus panels being used; as a consequence, the leukemia \& lymphoma (L\&L) testing remains a single-vial antibody being used, with various in-house laboratory developed tests (LDTs) being used to test patient specimens. Furthermore, the analysis of flow cytometer generated data is not standardized and requires a high level of expertise/training for interpretation of complex data. Therefore, optimized and standardized immunostaining protocols for the diagnosis, classification, and prognostic sub-classification of hematological malignancies are needed.
This Investigational panel for plasma cell disorders is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell populations on the BD FACSLyric flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, plasma cell disorders.
Enrollment will occur at up to 8 investigational sites . Data will be acquired from Eligible remnant/leftover specimens on the BD FACSLyric flow cytometer and evaluated by site personnel and expert analysts .
The final diagnosis and the affected cell population will be determined by site standard of care .
Analysis of data will evaluate identification of normal vs abnormal cell population of the expert \& site analysts as compared to the final diagnosis.
- Conditions
- Plasma Cell Disorder
- Being tested
- IUO Plasma Cell Disorders Panel
- Keywords
- leukemia & lymphoma
- Medical subject headings
- Neoplasms, Plasma Cell, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUO Plasma Cell Disorders PanelDiagnostic test
This Investigational Panel , comprised of 2 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, plasma cell disorders.
| Study group | Role | What they receive |
|---|---|---|
| Remnant/ Leftover specimens | Specimens that meet inclusion/exclusions criteria and are leftover from routine flow cytometry testing for plasma cell disorders Receives: Diagnostic Test: IUO Plasma Cell Disorders Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis
Determine equivalence between the investigational OneFlow PCD Panel on FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for normal polyclonal plasma cells or abnormal plasma cells using leftover, hematologically abnormal specimens.
Sensitivity and specificity will be calculated .
Measured: Age of specimen for Peripheral Blood (PB) andBone Marrow (BM) (time of collection to start of first pre-wash): ≤ 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start4 May 2021
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Imelda Omana-Zapata, MD, PHD, Study director, Becton, Dickinson and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032339
- Sponsor's protocol ID
- CAS-OFLYRICPP-IVDR
- Status last verified
- Oct 2023
- First submitted
- 27 Aug 2021
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Plasma Cell Disorders Panel (BD OneFlow™ PCST and BD OneFlow™ PCD) on the BD FACSLyric™ Flow Cytometer Using Leftover, De-identified Specimens
- ClinicalTrials.gov ID
- NCT05032339
- Acronym / sponsor ID
- CAS-OFLYRICPP-IVDR
- Conditions
- Plasma Cell Disorder
- Keywords
- leukemia & lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 May 2021 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-site, prospective performance study to determine equivalency between the investigational OneFlow PCD panel on the FACSLyric system versus the final clinical diagnosis.
Detailed description
Hematology laboratories rely on flow cytometry technology (in addition to classic hematological methods) to aid in screening, diagnosing, and monitoring patients with hematological disorders. High speed and broad applicability of flow cytometry allows for the diagnosis and accurate focus on targets. Currently, there are no general consensus panels being used; as a consequence, the leukemia \& lymphoma (L\&L) testing remains a single-vial antibody being used, with various in-house laboratory developed tests (LDTs) being used to test patient specimens. Furthermore, the analysis of flow cytometer generated data is not standardized and requires a high level of expertise/training for interpretation of complex data. Therefore, optimized and standardized immunostaining protocols for the diagnosis, classification, and prognostic sub-classification of hematological malignancies are needed.
This Investigational panel for plasma cell disorders is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell populations on the BD FACSLyric flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, plasma cell disorders.
Enrollment will occur at up to 8 investigational sites . Data will be acquired from Eligible remnant/leftover specimens on the BD FACSLyric flow cytometer and evaluated by site personnel and expert analysts .
The final diagnosis and the affected cell population will be determined by site standard of care .
Analysis of data will evaluate identification of normal vs abnormal cell population of the expert \& site analysts as compared to the final diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remnant/ Leftover specimens | – | Diagnostic Test: IUO Plasma Cell Disorders PanelSpecimens that meet inclusion/exclusions criteria and are leftover from routine flow cytometry testing for plasma cell disorders |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of 150 remnant/leftover bone marrow specimens from routine flow cytometry laboratory testing for plasma cell disorders, other hematological disorders, non-hematological tumors, and other hematological disorders (non-malignant). Specimens from healthy subjects will be excluded. At least 75 specimens must have abnormal plasma cells, at least 75 must have normal polyclonal plasma cells. Specimens are from subjects irrespective of race, gender, and ethnicity. Subjects above 22 years of age
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IUO Plasma Cell Disorders PanelThis Investigational Panel , comprised of 2 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, plasma cell disorders. | Diagnostic test | Remnant/ Leftover specimens |
Primary outcome
Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis
Time frame: Age of specimen for Peripheral Blood (PB) andBone Marrow (BM) (time of collection to start of first pre-wash): ≤ 24 hours.
Determine equivalence between the investigational OneFlow PCD Panel on FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for normal polyclonal plasma cells or abnormal plasma cells using leftover, hematologically abnormal specimens. Sensitivity and specificity will be calculated .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imelda Omana-Zapata, MD, PHD study director
Becton, Dickinson and Company
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasma Cell Disorder, run by Becton, Dickinson and Company at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Portugal, Spain, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis (time frame: Age of specimen for Peripheral Blood (PB) andBone Marrow (BM) (time of collection to start of first pre-wash): ≤ 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.