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Evaluation of ClearLLab Leukemia and Lymphoma Panels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03413644
Recruitment Status : Completed
First Posted : January 29, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Beckman Coulter, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Leukemia-Lymphoma Diagnostic Test: Flow Cytometry

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
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Study Type : Observational
Actual Enrollment : 482 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of ClearLLab Leukemia and Lymphoma Panels
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : April 27, 2018
Actual Study Completion Date : April 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Flow Cytometry
    Immunophenotyping of residual clinical samples tested with ClearLLab diagnostic reagent on a specified Flow Cytometer

Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Specimens from new cases or follow up patients suspected of having a hematological malignancy and present with symptoms based on Bethesda guidelines.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413644


Locations
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United States, Florida
NeoGenomics Laboratories, Inc.
Fort Myers, Florida, United States, 33913
Canada, Alberta
Calgary Laboratory Services
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
London Health Sciences Center
London, Ontario, Canada, N6A 5W9
Germany
Munich Leukemia Laboratory
Munich, Germany, 81377
Sponsors and Collaborators
Beckman Coulter, Inc.
Investigators
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Principal Investigator: Adrian Padurean, MD NeoGenomics Laboratories, Inc.
Principal Investigator: Mike Keeney London Health Sciences Center
Principal Investigator: Joanne Luider Calgary Laboratory Services
Principal Investigator: Wolfgang Kern Munich Leukemia Laboratory
More Information
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Responsible Party: Beckman Coulter, Inc.
ClinicalTrials.gov Identifier: NCT03413644    
Other Study ID Numbers: B88558
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Beckman Coulter, Inc.:
Hematological diseases
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases