Leukemia-LymphomaNCT03413644
Evaluation of ClearLLab Leukemia and Lymphoma Panels
An observational study of Leukemia-Lymphoma, run by Beckman Coulter, Inc. at 4 sites in 3 countries.
Trial summary
Multi-center study of specimens from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematological diseases work-up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia-Lymphoma
- What is being tested?
- Flow Cytometry
- How many people
- 482 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 14 Nov 2017to 27 Apr 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Specimens from new cases or follow up patients suspected of having a hematological malignancy and present with symptoms based on Bethesda guidelines.
Who may be able to join
- Residual samples from patients with hematological abnormalities being evaluated by Flow Cytometry for the presence or absence of an abnormal population associated with a hematological malignancy. All subjects of any ethnicity, age and racial background will be included.
Who cannot join
- Specimens and/or spent samples that are visibly hemolyzed
- Specimens and/or spent samples that are visibly clotted
- Specimens and/or spent samples collected in K2EDTA anticoagulant older than 24 hours from time of collection
- Specimens and/or spent samples collected in Heparin or ACD anticoagulant older than 48 hours from time of collection
- Samples with insufficient volume to complete the protocol tests
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Canada2 sites
Calgary Laboratory Services
Calgary, Alberta, T2N 2T9
London Health Sciences Center
London, Ontario, N6A 5W9
United States1 site
NeoGenomics Laboratories, Inc.
Fort Myers, Florida, 33913
About this study
Multi-center study of specimens from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematological diseases work-up.
Read the detailed description
Multi-center study of specimens from subjects presenting for flow cytometry immunophenotyping as part of their standard of care for hematological diseases work-up. Residual specimens will be tested using the ClearLLab Panels to determine the presence or absence of an abnormal phenotype and compare results to clinical impression (hematological malignancy or non-malignancy).
- Conditions
- Leukemia-Lymphoma
- Being tested
- Flow Cytometry
- Keywords
- Hematological diseases
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow CytometryDiagnostic test
Immunophenotyping of residual clinical samples tested with ClearLLab diagnostic reagent on a specified Flow Cytometer
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologically Malignant or Non-Malignant
Presence or absence of an abnormal phenotype detected using the ClearLLab Panels vs. the clinical outcome of "Hematologically Malignant" or "Hematologically Non-Malignant" from the same subject
Measured: Residual samples must be tested within 24 hours of collection in K2EDTA or within 48 hours of collection in Heparin or ACD anticoagulants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start14 Nov 2017
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia-LymphomaStudies 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
- Prospective
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Padurean, MD, Principal investigator, NeoGenomics Laboratories, Inc.Mike Keeney, Principal investigator, London Health Sciences CenterJoanne Luider, Principal investigator, Calgary Laboratory ServicesWolfgang Kern, Principal investigator, Munich Leukemia Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413644
- Sponsor's protocol ID
- B88558
- Status last verified
- Jul 2018
- First submitted
- 22 Jan 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ClearLLab Leukemia and Lymphoma Panels
- ClinicalTrials.gov ID
- NCT03413644
- Acronym / sponsor ID
- B88558
- Conditions
- Leukemia-Lymphoma
- Keywords
- Hematological diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 29 Jan 2018 (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-center study of specimens from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematological diseases work-up.
Detailed description
Multi-center study of specimens from subjects presenting for flow cytometry immunophenotyping as part of their standard of care for hematological diseases work-up. Residual specimens will be tested using the ClearLLab Panels to determine the presence or absence of an abnormal phenotype and compare results to clinical impression (hematological malignancy or non-malignancy).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Specimens from new cases or follow up patients suspected of having a hematological malignancy and present with symptoms based on Bethesda guidelines.
Key inclusion criteria (1 listed)
- Residual samples from patients with hematological abnormalities being evaluated by Flow Cytometry for the presence or absence of an abnormal population associated with a hematological malignancy. All subjects of any ethnicity, age and racial background will be included.
Key exclusion criteria (5 listed)
- Specimens and/or spent samples that are visibly hemolyzed
- Specimens and/or spent samples that are visibly clotted
- Specimens and/or spent samples collected in K2EDTA anticoagulant older than 24 hours from time of collection
- Specimens and/or spent samples collected in Heparin or ACD anticoagulant older than 48 hours from time of collection
- Samples with insufficient volume to complete the protocol tests
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 |
|---|---|---|
| Flow CytometryImmunophenotyping of residual clinical samples tested with ClearLLab diagnostic reagent on a specified Flow Cytometer | Diagnostic test | – |
Primary outcome
Hematologically Malignant or Non-Malignant
Time frame: Residual samples must be tested within 24 hours of collection in K2EDTA or within 48 hours of collection in Heparin or ACD anticoagulants
Presence or absence of an abnormal phenotype detected using the ClearLLab Panels vs. the clinical outcome of "Hematologically Malignant" or "Hematologically Non-Malignant" from the same subject
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 13 Jul 2018.
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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.
Adrian Padurean, MD principal investigator
NeoGenomics Laboratories, Inc.
Mike Keeney principal investigator
London Health Sciences Center
Joanne Luider principal investigator
Calgary Laboratory Services
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia-Lymphoma, run by Beckman Coulter, Inc. at 4 sites in 3 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 1 inclusion and 5 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, United States, Germany. 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?
Hematologically Malignant or Non-Malignant (time frame: Residual samples must be tested within 24 hours of collection in K2EDTA or within 48 hours of collection in Heparin or ACD anticoagulants). 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 13 Jul 2018.