Evaluation of ClearLLab LS Screening Panel

• Sponsor: Beckman Coulter, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05819762
• Collaborator: Institute of Hematology & Blood Diseases Hospital (Other), The First Affiliated Hospital of Soochow University (Other), The First Affiliated Hospital with Nanjing Medical University (Other)
• Enrollment: 800
• Locations: 3
• Anticipated Duration (Months): 11
• Patients Per Site: 266.7
• Patients Per Site Per Month: 24.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancy; Hematologic Neoplasms; Hematologic Diseases	Diagnostic Test: Flow Cytometry

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 800 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of ClearLLab LS Screening Panel for the Diagnosis of Hematological Malignancies
• Anticipated Study Start Date: Apr 30, 2023
• Anticipated Primary Completion Date: Mar 30, 2024
• Anticipated Study Completion Date: Mar 30, 2024

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China
2	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China
3	Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Tianjin		China

Sponsors and Collaborators

• Beckman Coulter, Inc.
• Institute of Hematology & Blood Diseases Hospital
• The First Affiliated Hospital of Soochow University
• The First Affiliated Hospital with Nanjing Medical University

Investigators

• Study Director: China Clinical Affaris, Beckman Coulter, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beckman Coulter, Inc.
• ClinicalTrials.gov Identifier: NCT05819762
• Other Study ID Numbers: CHN186
• First Posted: Apr 19, 2023
• Last Update Posted: Apr 19, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms; Hematologic Diseases

Study Results

No Results Posted as of Apr 19, 2023