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Completed

NCT Number: NCT05819762

Evaluation of ClearLLab LS Screening Panel

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.

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Key information

Conditions

Hematologic Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital, Wuhan, Hubei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Flow Cytometry

Diagnostic Test

Immunophenotyping of residual clinical samples tested with ClearLLab LS screening panel on a specified Flow Cytometry

Primary outcomes

  1. Diagnostic accuracy: sensitivity and specificity

    Time frame: Baseline

    Diagnostic accuracy measured as sensitivity and specificity of ClearLLab LS screening panel in identifying hematological malignancies and non-malignancies compared with the clinical criteria (WHO guidelines)

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China
  • The First Affiliated Hospital of Soochow University
  • The First Affiliated Hospital with Nanjing Medical University
  • Tongji Hospital

Registry information

Official study title

Evaluation of ClearLLab LS Screening Panel for the Diagnosis of Hematological Malignancies

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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