Evaluation of ClearLLab Leukemia and Lymphoma Panels

July 11, 2018 updated by: Beckman Coulter, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

482

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Calgary Laboratory Services
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Center
  • Germany
      • Munich, Germany, 81377
        • Munich Leukemia Laboratory
  • United States
    • Florida
      • Fort Myers, Florida, United States, 33913
        • NeoGenomics Laboratories, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Residual samples must be tested within 24 hours of collection in K2EDTA or within 48 hours of collection in Heparin or ACD anticoagulants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beckman Coulter, Inc.

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2017

Primary Completion (Actual)

April 27, 2018

Study Completion (Actual)

April 27, 2018

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B88558

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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