DxFLEX 10C Clinical Study

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

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.

Study Overview

• Status: Completed
• Conditions: Hematological Malignancy
• Intervention / Treatment: Device: DxFLEX 10C

• Study Type: Observational
• Enrollment (Actual): 527

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5G5
      • London Health Sciences Centre
• Germany
  • Munich, Germany, 81377
    • Munich Leukemia Laboratory (MLL)
• United States
  • California
    • Aliso Viejo, California, United States, 92656
      • NeoGenomics Laboratories
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
  • Texas
    • Lewisville, Texas, United States, 75067
      • Quest Diagnostics
  • Washington
    • Seattle, Washington, United States, 98134
      • PhenoPath Laboratories, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Intended L&L population

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hematologically normal; Based on immunophenotyping	Device: DxFLEX 10C; A device combining flow cytometry and reagents for immunophenotyping analysis
Hematologically abnormal; Based on immunophenotyping	Device: DxFLEX 10C; A device combining flow cytometry and reagents for immunophenotyping analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow immunophenotyped normal and abnormal	Based on WHO guidelines for Leukemia & Lymphoma	immediately after the analysis

Collaborators and Investigators

• Sponsor: Beckman Coulter, Inc.
• Investigators: Study Director: Guoyan Cheng, PhD, Beckman Coulter, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: C76895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes