Evaluation of ClearLLab Leukemia and Lymphoma Panels

Beckman Coulter

Status: Completed

Conditions: Leukemia-Lymphoma

Treatments: Diagnostic Test: Flow Cytometry

Study type: Observational

Funder types: Industry

Identifiers

NCT03413644

B88558

Details and patient eligibility

About

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.

Full 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).

Enrollment: 482 patients

Sex: All

Volunteers: No Healthy Volunteers

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