NCT05467449

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
527

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

July 15, 2022

Last Update Submit

February 12, 2024

Conditions

Hematological Malignancy

Outcome Measures

Primary Outcomes (1)

  • Flow immunophenotyped normal and abnormal

    Based on WHO guidelines for Leukemia \& Lymphoma

    immediately after the analysis

Study Arms (2)

Hematologically normal

Based on immunophenotyping

Device: DxFLEX 10C

Hematologically abnormal

Based on immunophenotyping

Device: DxFLEX 10C

Interventions

DxFLEX 10CDEVICE

A device combining flow cytometry and reagents for immunophenotyping analysis

Hematologically abnormalHematologically normal

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Intended L\&L population

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

NeoGenomics Laboratories

Aliso Viejo, California, 92656, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Quest Diagnostics

Lewisville, Texas, 75067, United States

Location

PhenoPath Laboratories, PLLC

Seattle, Washington, 98134, United States

Location

London Health Sciences Centre

London, Ontario, N6A 5G5, Canada

Location

Munich Leukemia Laboratory (MLL)

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Guoyan Cheng, PhD

    Beckman Coulter, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 20, 2022

Study Start

April 12, 2022

Primary Completion

May 31, 2023

Study Completion

August 31, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(4)DE(1)