NCT05819762

Evaluation of ClearLLab LS Screening Panel

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 831 (actual)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hematologic Malignancy
• Hematologic Neoplasms
• Hematologic Diseases

Interventions

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

Timeline

• Start date: 2023-05-25
• Primary completion: 2024-10-15
• Completion: 2024-11-18
• First posted: 2023-04-19
• Last updated: 2024-12-04

Locations

4 sites across 1 country: China