Evaluation of ClearLLab Leukemia and Lymphoma Panels

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03413644

Enrollment

482

Registered

2018-01-29

Start date

2017-11-14

Completion date

2018-04-27

Last updated

2018-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia-Lymphoma

Keywords

Hematological diseases

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).

Interventions

DIAGNOSTIC_TESTFlow Cytometry

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Canada, Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026