Chronic Lymphoproliferative Diseases (CLPD)NCT05557422
BD OneFlow CLPD Panel (BD OneFlow LST, and B-CLPD T1 to T4 Assays) on the BD FACSLyric System.
An observational study of Chronic Lymphoproliferative Diseases (CLPD), run by Becton, Dickinson and Company at 6 sites in 5 countries.
Trial summary
Multi-site, prospective performance study to determine equivalency between the investigational CLPD Full 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
- Chronic Lymphoproliferative Diseases (CLPD)
- What is being tested?
- BD OneFlow LST, and B-CLPD T1 to T4 Assays
- How many people
- 322 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 12 Oct 2022to 8 May 2024
- 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 evaluable 250 remnant/leftover peripheral blood, bone marrow, and lymph node specimens from routine flow cytometry laboratory testing for hematological disorders. Specimens from healthy subjects will be excluded. Specimens are from subjects irrespective of race, gender, and ethnicity. Specimen from subject >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 (min 700 µL or more) to complete protocol tests.
- Specimen is leftover PB, BM, or LT from routine flow cytometry laboratory testing for chronic lymphoproliferative disorders, other hematological disorders, non-hematological tumors (e.g., solid tumors), or other hematological disorders (non-malignant).
- Specimen is from subjects previous diagnosed, newly diagnosed and/or relapsed disease.
- Only one type of specimen, either PB, BM, or LT shall be enrolled per given subject.
- Specimen is stored at room temperature, upon receipt by the site.
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- PB and BM specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium).
- LT 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 LT)
- Specimens are from subjects irrespective of race, gender, and ethnicity
Who cannot join
- 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.
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- Visibly hemolyzed specimen.
- Frozen specimen.
- Refrigerated specimen.
- Fixed specimen.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
United States2 sites
University of Norht Calolina
Chapel Hill, North Carolina, 27514
CorePATH Laboratories
San Antonio, Texas, 78256
Netherlands1 site
Erasmus Medical Center, Laboratory Medical Immunology, Department of Immunology
Rotterdam, 3015 GD
About this study
Official title: Clinical Performance Evaluation of the BD OneFlow CLPD Panel (BD OneFlow LST, and B-CLPD T1 to T4 Assays) on the BD FACSLyric System.
Multi-site, prospective performance study to determine equivalency between the investigational CLPD Full Panel on the FACSLyric system versus the final clinical diagnosis.
Read the detailed description
This study is a multi-site and multi-regional prospective performance evaluation to determine sensitivity and specificity of the investigational BD OneFlow CLPD Panel on the FACSLyric system when compared to the results from the Expert Analysis for market launch.
The study will be conducted at up to eight investigational sites that have previously participated in the BD OneFlow program clinical studies and/or have expertise in flow cytometric immunophenotyping, interpretation, and diagnosis of Leukemia and Lymphoma (L\&L). Each site will have one 10- or 12-color FACSLyric instrument with Universal Loader (Loader).
This study will enroll at least 250 leftover de-identified PB, BM, and LT specimens from routine flow cytometry laboratory testing for hematological disorders or non-hematological disorders that provide valid results and are considered evaluable specimens. Each site will enroll a minimum of 25 evaluable specimens and a maximum of approximately 70 evaluable specimens with normal and abnormal lymphoid cell immunophenotype.
To ensure that the study satisfies enrollment by specimen type, this study will enroll lymphoid tissue specimens. Lymphoid tissue (LT) refers to organs/tissues supporting immune responses, which includes primary lymphoid tissue (BM and thymus), and secondary lymphoid tissue (lymph nodes, tonsils, spleen, and Peyer's patches). Their morphological structure is related to its function in the immune system. For this study, the term LT will be used to refer the secondary lymphoid tissue only.
Evaluable specimens will be enrolled to meet the binning requirements for specimen type, normal vs abnormal cell phenotype, and disease type, as described in Tables 3-5.
Specimens will be prepared using a minimum of three lots of the OneFlow LST and OneFlow B-CLPD T1 to T4 reagent kits across investigational sites. Stained samples will be acquired on the BD FACSLyric using the BD FACSuite Clinical application with the assay modules for each of the tubes. Results will be analyzed by the laboratory staff. In addition, the sites will collect the "Final Clinical Diagnosis" from each sample.
The study includes an "Expert Analysis." This will be conducted by qualified Experts by training and experience, who will receive the files with raw data, analyze and designate cell immune phenotype. Two Experts will analyze the data from each sample. The results from the Expert Analysis will be compared to the site's Final Clinical Diagnosis and the study acceptance criteria for the study endpoints.
- Being tested
- BD OneFlow LST, and B-CLPD T1 to T4 Assays
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD OneFlow LST, and B-CLPD T1 to T4 AssaysDiagnostic test
a panel of fluorochrome-conjugated antibodies for qualitative flow-cytometric immunophenotyping of mature lymphocyte populations on the BD FACSLyric™ flow cytometer with BD FACSuite™ Clinical application.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between expert analysis determination for normal and abnormal specimen and final dignosis
Determine equivalence between the investigational OneFlow CLPD panel on FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (T-cell, B-cell, and NK-cell) or Abnormal (T-cell or B-cell or NK-cell) phenotype using leftover, hematologically abnormal specimens.
Measured: Age of Specimen for PB and BM (time of collection to start of first pre-washed) <24 hours
Secondary outcomes (1)
Comparison between expert analysis determination for normal and abnormal Peripheral Blood (PB) specimen and final dignosis
Supplement equivalence between the investigational OneFlow CLPD on FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (T-cell, B-cell, and NK-cell) or Abnormal (T-cell or B-cell or NK-cell) phenotype using leftover, hematologically abnormal peripheral blood (PB) specimens.
Measured: ge of Specimen for PB (time of collection to start of first pre-washed) <24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start12 Oct 2022
- Primary completion8 May 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphoproliferative Diseases (CLPD)Studies 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
- 322 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, Ph.D, Study director, Becton, Dickinson and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557422
- Sponsor's protocol ID
- CAS-OFLBT1T4
- Status last verified
- Mar 2024
- First submitted
- 23 Sep 2022
- Last updated
- 26 Sep 2024
- 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of the BD OneFlow CLPD Panel (BD OneFlow LST, and B-CLPD T1 to T4 Assays) on the BD FACSLyric System.
- ClinicalTrials.gov ID
- NCT05557422
- Acronym / sponsor ID
- CAS-OFLBT1T4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 28 Sep 2022 (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 CLPD Full Panel on the FACSLyric system versus the final clinical diagnosis.
Detailed description
This study is a multi-site and multi-regional prospective performance evaluation to determine sensitivity and specificity of the investigational BD OneFlow CLPD Panel on the FACSLyric system when compared to the results from the Expert Analysis for market launch.
The study will be conducted at up to eight investigational sites that have previously participated in the BD OneFlow program clinical studies and/or have expertise in flow cytometric immunophenotyping, interpretation, and diagnosis of Leukemia and Lymphoma (L\&L). Each site will have one 10- or 12-color FACSLyric instrument with Universal Loader (Loader).
This study will enroll at least 250 leftover de-identified PB, BM, and LT specimens from routine flow cytometry laboratory testing for hematological disorders or non-hematological disorders that provide valid results and are considered evaluable specimens. Each site will enroll a minimum of 25 evaluable specimens and a maximum of approximately 70 evaluable specimens with normal and abnormal lymphoid cell immunophenotype.
To ensure that the study satisfies enrollment by specimen type, this study will enroll lymphoid tissue specimens. Lymphoid tissue (LT) refers to organs/tissues supporting immune responses, which includes primary lymphoid tissue (BM and thymus), and secondary lymphoid tissue (lymph nodes, tonsils, spleen, and Peyer's patches). Their morphological structure is related to its function in the immune system. For this study, the term LT will be used to refer the secondary lymphoid tissue only.
Evaluable specimens will be enrolled to meet the binning requirements for specimen type, normal vs abnormal cell phenotype, and disease type, as described in Tables 3-5.
Specimens will be prepared using a minimum of three lots of the OneFlow LST and OneFlow B-CLPD T1 to T4 reagent kits across investigational sites. Stained samples will be acquired on the BD FACSLyric using the BD FACSuite Clinical application with the assay modules for each of the tubes. Results will be analyzed by the laboratory staff. In addition, the sites will collect the "Final Clinical Diagnosis" from each sample.
The study includes an "Expert Analysis." This will be conducted by qualified Experts by training and experience, who will receive the files with raw data, analyze and designate cell immune phenotype. Two Experts will analyze the data from each sample. The results from the Expert Analysis will be compared to the site's Final Clinical Diagnosis and the study acceptance criteria for the study endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of evaluable 250 remnant/leftover peripheral blood, bone marrow, and lymph node specimens from routine flow cytometry laboratory testing for hematological disorders. Specimens from healthy subjects will be excluded. Specimens are from subjects irrespective of race, gender, and ethnicity. Specimen from subject >22 years of age .
Key inclusion criteria (10 listed)
- Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
- Specimen with adequate volume (min 700 µL or more) to complete protocol tests.
- Specimen is leftover PB, BM, or LT from routine flow cytometry laboratory testing for chronic lymphoproliferative disorders, other hematological disorders, non-hematological tumors (e.g., solid tumors), or other hematological disorders (non-malignant).
- Specimen is from subjects previous diagnosed, newly diagnosed and/or relapsed disease.
- Only one type of specimen, either PB, BM, or LT shall be enrolled per given subject.
Key exclusion criteria (10 listed)
- 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).
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 |
|---|---|---|
| BD OneFlow LST, and B-CLPD T1 to T4 Assaysa panel of fluorochrome-conjugated antibodies for qualitative flow-cytometric immunophenotyping of mature lymphocyte populations on the BD FACSLyric™ flow cytometer with BD FACSuite™ Clinical application. | Diagnostic test | – |
Primary outcome
Comparison between expert analysis determination for normal and abnormal specimen and final dignosis
Time frame: Age of Specimen for PB and BM (time of collection to start of first pre-washed) <24 hours
Determine equivalence between the investigational OneFlow CLPD panel on FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (T-cell, B-cell, and NK-cell) or Abnormal (T-cell or B-cell or NK-cell) phenotype using leftover, hematologically abnormal specimens.
1 secondary outcome
Comparison between expert analysis determination for normal and abnormal Peripheral Blood (PB) specimen and final dignosis
Time frame: ge of Specimen for PB (time of collection to start of first pre-washed) <24 hours.
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 26 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Lymphoproliferative Diseases (CLPD)
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Chronic Lymphoproliferative Disease
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, Ph.D study director
Becton, Dickinson and Company
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphoproliferative Diseases (CLPD), run by Becton, Dickinson and Company at 6 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 10 inclusion and 10 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 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Netherlands, Portugal, Spain, Switzerland. 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 analysis determination for normal and abnormal specimen and final dignosis (time frame: Age of Specimen for PB and BM (time of collection to start of first pre-washed) <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 26 Sep 2024.