DxFLEX 10C Clinical Study

Completed

• Conditions: Hematological Malignancy
• Interventions: Device: DxFLEX 10C

• Registration Number: NCT05467449
• Lead Sponsor: Beckman Coulter, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-12
• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-20
• Primary Completion: 2023-05-31
• Study Completion: 2023-08-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 527

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hematologically normal	DxFLEX 10C	Based on immunophenotyping
Hematologically abnormal	DxFLEX 10C	Based on immunophenotyping

Primary Outcome Measures

Name	Time	Method
Flow immunophenotyped normal and abnormal	immediately after the analysis	Based on WHO guidelines for Leukemia \& Lymphoma

Trial Locations

Locations (6)

Munich Leukemia Laboratory (MLL); 🇩🇪 Munich, Germany

Quest Diagnostics; 🇺🇸 Lewisville, Texas, United States

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

PhenoPath Laboratories, PLLC; 🇺🇸 Seattle, Washington, United States

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

NeoGenomics Laboratories; 🇺🇸 Aliso Viejo, California, United States