Evaluation of ClearLLab Leukemia and Lymphoma Panels

NCT ID: NCT03413644

Last Updated: 2018-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

482 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-14

Study Completion Date

2018-04-27

Brief Summary

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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

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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

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Leukemia-Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Flow Cytometry

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beckman Coulter, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian Padurean, MD

Role: PRINCIPAL_INVESTIGATOR

NeoGenomics Laboratories, Inc.

Mike Keeney

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Center

Joanne Luider

Role: PRINCIPAL_INVESTIGATOR

Calgary Laboratory Services

Wolfgang Kern

Role: PRINCIPAL_INVESTIGATOR

Munich Leukemia Laboratory

Locations

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NeoGenomics Laboratories, Inc.

Fort Myers, Florida, United States

Site Status

Calgary Laboratory Services

Calgary, Alberta, Canada

Site Status

London Health Sciences Center

London, Ontario, Canada

Site Status

Munich Leukemia Laboratory

Munich, , Germany

Site Status

Countries

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United States Canada Germany

Other Identifiers

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B88558

Identifier Type: -

Identifier Source: org_study_id

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