DxFLEX 10C Clinical Study | NCT05467449

Studies
DxFLEX 10C Clinical Study

NCT05467449

Sponsor

Beckman Coulter, Inc.

Status

Completed

Last Update Posted

Feb 13, 2024Actual

Enrollment

527Actual

Phase

Not provided

Conditions

Hematological Malignancy

Interventions

DxFLEX 10C

Countries

United States
Canada
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2022Actual

Primary Completion Date

May 31, 2023Actual

Completion Date

Aug 31, 2023Actual

First Submitted Date

Jul 15, 2022

First Submission Date that Met QC Criteria

Jul 19, 2022

First Posted Date

Jul 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2024

Last Update Posted Date

Feb 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

527Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hematologically normal		Based on immunophenotyping	Device: DxFLEX 10C
Hematologically abnormal		Based on immunophenotyping	Device: DxFLEX 10C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DxFLEX 10C	Device	A device combining flow cytometry and reagents for immunophenotyping analysis	Hematologically abnormal Hematologically normal

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Intended L&L population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guoyan Cheng, PhD	Beckman Coulter, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NeoGenomics Laboratories		Aliso Viejo	California	92656	United States
University of Miami Miller School of Medicine

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided