Evaluation of ClearLLab Leukemia and Lymphoma Panels

Completed

• Conditions: Leukemia-Lymphoma

• Registration Number: NCT03413644
• Lead Sponsor: Beckman Coulter, Inc.

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.

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 Timeline

• Study Start: 2017-11-14
• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Primary Completion: 2018-04-27
• Study Completion: 2018-04-27
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 482

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hematologically Malignant or Non-Malignant	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

Trial Locations

Locations (4)

Calgary Laboratory Services; 🇨🇦 Calgary, Alberta, Canada

London Health Sciences Center; 🇨🇦 London, Ontario, Canada

Munich Leukemia Laboratory; 🇩🇪 Munich, Germany

NeoGenomics Laboratories, Inc.; 🇺🇸 Fort Myers, Florida, United States