Evaluation of ClearLLab LS Screening Panel

Last updated: December 2, 2024
Sponsor: Beckman Coulter, Inc.
Overall Status: Completed

Phase

N/A

Condition

Neoplasms

Red Blood Cell Disorders

Blood Cancer

Treatment

Flow Cytometry

Clinical Study ID

NCT05819762
CHN186
  • All Genders

Study Summary

This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Residual whole blood, bone marrow, or lymph node tissue samples from subjects withhematologic tumor-related symptoms and/or signs that are clinically recommended forFlow Cytometry Immunophenotyping

Exclusion

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 Ethylene Diamine Tetraacetic Acid (EDTA)anticoagulant older than 24 hours from time of collection

  • Specimens and/or spent samples collected in Heparin or Acid Citrate-Dextrose (ACD)anticoagulant older than 48 hours from time of collection

  • Samples with insufficient volume to complete the protocol tests

  • Samples from subjects with known myeloid malignancies or multiple myeloma

Study Design

Total Participants: 831
Treatment Group(s): 1
Primary Treatment: Flow Cytometry
Phase:
Study Start date:
May 25, 2023
Estimated Completion Date:
November 18, 2024

Study Description

This study aims to evaluate the clinical accuracy of ClearLLab LS screening panel in the diagnosis of hematologic malignancies. The residual specimens, which from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematologic diseases work-up, will be tested by ClearLLab LS screening panel. ClearLLab LS screening panel is CE-IVD marked immunophenotyping reagents under the European Union (EU) regulation, and this study is aimed to validate its clinical performance in Chinese population.

Connect with a study center

  • Tongji Hospital

    Wuhan, Hubei
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Site Not Available

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Tianjin,
    China

    Site Not Available

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