Evaluation of ClearLLab Leukemia and Lymphoma Panels

Leukemia-Lymphoma Clinical Trial

Official title:

Evaluation of ClearLLab Leukemia and Lymphoma Panels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413644
• Other study ID #: B88558
• Status: Completed
• Start date: November 14, 2017
• Est. completion date: April 27, 2018

Study information

• Verified date: July 2018
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: April 27, 2018
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia-Lymphoma
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
Canada	Calgary Laboratory Services	Calgary	Alberta
Canada	London Health Sciences Center	London	Ontario
Germany	Munich Leukemia Laboratory	Munich
United States	NeoGenomics Laboratories, Inc.	Fort Myers	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologically Malignant or Non-Malignant	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