DxFLEX 10C Clinical Study

A multi-center method comparison study is designed per CLSI-EP09 A3. This study compares the qualitative immunophenotype agreement between DxFLEX and Navios EX to demonstrate the accuracy of the DxFLEX-10C system. A series of precision studies will be conducted with each focusing on different aspects of the DxFLEX-10C system.

Completed

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Key information

Conditions

Hematological Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

London Health Sciences Centre, London, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient specimens targeted for this study will be residual samples with sufficient volume from whole blood, bone marrow, and lymph node meeting the following criteria:

Specimens from new cases or follow up patients for myeloid/lymphoid FCI testing.
Hematologically abnormal specimens
Subjects of any range, ethnicities, and racial backgrounds
Specimens from patients with the following medical indications presenting for testing by flow cytometry based on the Bethesda Consensus Guidelines.

Exclusion criteria

There are two (2) groups of exclusion criteria to detail the specimens that should not be counted for the study:

Pre-analytical/Pre-screen exclusion criteria
Post-acquisition exclusion criteria.

Treatment and study plan

DxFLEX 10C

Device

A device combining flow cytometry and reagents for immunophenotyping analysis

Primary outcomes

Flow immunophenotyped normal and abnormal

Time frame: immediately after the analysis

Based on WHO guidelines for Leukemia & Lymphoma

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Registry information

Official study title

DxFLEX ClearLLab 10C US-IVD Clinical Study Protocol - Clinical Laboratory

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jul 20, 2022
Registry last updated: Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed