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Completed

NCT Number: NCT03413644

Evaluation of ClearLLab Leukemia and Lymphoma Panels

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.

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Key information

Conditions

Leukemia-Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Calgary Laboratory Services, Calgary, Alberta, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flow Cytometry

Diagnostic Test

Immunophenotyping of residual clinical samples tested with ClearLLab diagnostic reagent on a specified Flow Cytometer

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2018
Registry last updated
Jul 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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