Evaluation of ClearLLab LS Screening Panel

Completed

• Conditions: Hematologic Neoplasms; Hematologic Malignancy; Hematologic Diseases

• Registration Number: NCT05819762
• Lead Sponsor: Beckman Coulter, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-19
• Study Start: 2023-05-25
• Status Verified: 2024-04
• Primary Completion: 2024-10-15
• Study Completion: 2024-11-18
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 831

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy: sensitivity and specificity	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)

Trial Locations

Locations (4)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Tianjin, China