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Evaluation of ClearLLab LS Screening Panel

NCT ID: NCT05819762

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

831 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-25

Study Completion Date

2024-11-18

Brief Summary

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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

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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

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Hematologic Malignancy Hematologic Neoplasms Hematologic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Flow Cytometry

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Beckman Coulter, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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China Clinical Affaris

Role: STUDY_DIRECTOR

Beckman Coulter, Inc.

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

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

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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CHN186

Identifier Type: -

Identifier Source: org_study_id