Evaluation of ClearLLab LS Screening Panel

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819762
• Other study ID #: CHN186
• Status: Recruiting
• Start date: May 25, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Beckman Coulter, Inc.
• Contact: Nancy Zhao, Ph.D.
• Phone: 021-38651008
• Email: xzhao04[@]beckman.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
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	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (5)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.	Institute of Hematology & Blood Diseases Hospital, China, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy: sensitivity and specificity	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)	Baseline