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DxFLEX 10C Clinical Study

Sponsor
Beckman Coulter, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05467449
Collaborator
(none)
500
Enrollment
6
Locations
8.6
Anticipated Duration (Months)
83.3
Patients Per Site
9.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: DxFLEX 10C

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
DxFLEX ClearLLab 10C US-IVD Clinical Study Protocol - Clinical Laboratory
Actual Study Start Date :
Apr 12, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Flow immunophenotyped normal and abnormal [immediately after the analysis]

    Based on WHO guidelines for Leukemia & Lymphoma

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NeoGenomics Laboratories Aliso Viejo California United States 92656
2 University of Miami Miller School of Medicine Miami Florida United States 33136
3 Quest Diagnostics Lewisville Texas United States 75067
4 PhenoPath Laboratories, PLLC Seattle Washington United States 98134
5 London Health Sciences Centre London Ontario Canada N6A 5G5
6 Munich Leukemia Laboratory (MLL) Munich Germany 81377

Sponsors and Collaborators

  • Beckman Coulter, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beckman Coulter, Inc.
ClinicalTrials.gov Identifier:
NCT05467449
Other Study ID Numbers:
  • C76895
First Posted:
Jul 20, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Hematologic Neoplasms

Study Results

No Results Posted as of Jul 20, 2022