Evaluation of ClearLLab LS Screening Panel

NCT05819762 | Completed

• 1 other identifier: CHN186
• Study Type: observational
• Target: 831
• Locations: 1 country
• Sites: 4

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.

Conditions

Hematologic Malignancy; Hematologic Neoplasms; Hematologic Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Flow Cytometry DIAGNOSTIC_TEST

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All subjects of any ethnicity, age and racial background will be included

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

Tongji Hospital

Wuhan, Hubei, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Tianjin, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Hematologic Diseases

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• China Clinical Affaris

  Beckman Coulter, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 19, 2023
• Study Start: May 25, 2023
• Primary Completion: October 15, 2024
• Study Completion: November 18, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)