Evaluation of ClearLLab Leukemia and Lymphoma Panels

NCT03413644 | Completed FDA Device

• 1 other identifier: B88558
• Study Type: observational
• Target: 482
• Locations: 3 countries
• Sites: 4

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.

Conditions

Leukemia-Lymphoma

Keywords

Hematological diseases

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Flow Cytometry DIAGNOSTIC_TEST

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Specimens from new cases or follow up patients suspected of having a hematological malignancy and present with symptoms based on Bethesda guidelines.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (4)

NeoGenomics Laboratories, Inc.

Fort Myers, Florida, 33913, United States

Location

Calgary Laboratory Services

Calgary, Alberta, T2N 2T9, Canada

Location

London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location

Munich Leukemia Laboratory

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Adrian Padurean, MD

  NeoGenomics Laboratories, Inc.

  PRINCIPAL INVESTIGATOR

• Mike Keeney

  London Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Joanne Luider

  Calgary Laboratory Services

  PRINCIPAL INVESTIGATOR

• Wolfgang Kern

  Munich Leukemia Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: November 14, 2017
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

DE (1); US (1); CA (2)