DxFLEX 10C Clinical Study

Hematological Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05467449
• Other study ID #: C76895
• Status: Completed
• Start date: April 12, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2024
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: August 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

1. Specimens from new cases or follow up patients for myeloid/lymphoid FCI testing.

2. Hematologically abnormal specimens

3. Subjects of any range, ethnicities, and racial backgrounds

4. 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:

1. Pre-analytical/Pre-screen exclusion criteria

2. Post-acquisition exclusion criteria.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy

Intervention

Device:
• DxFLEX 10C
A device combining flow cytometry and reagents for immunophenotyping analysis

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Germany	Munich Leukemia Laboratory (MLL)	Munich
United States	NeoGenomics Laboratories	Aliso Viejo	California
United States	Quest Diagnostics	Lewisville	Texas
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	PhenoPath Laboratories, PLLC	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow immunophenotyped normal and abnormal	Based on WHO guidelines for Leukemia & Lymphoma	immediately after the analysis