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Trial Title:
Evaluation of ClearLLab LS Screening Panel
NCT ID:
NCT05819762
Condition:
Hematologic Malignancy
Hematologic Neoplasms
Hematologic Diseases
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Hematologic Diseases
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Flow Cytometry
Description:
Immunophenotyping of residual clinical samples tested with ClearLLab LS screening panel
on a specified Flow Cytometry
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.
Criteria for eligibility:
Study pop:
All subjects of any ethnicity, age and racial background will be included
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Start date:
May 25, 2023
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Beckman Coulter, Inc.
Agency class:
Industry
Collaborator:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Source:
Beckman Coulter, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05819762
