Spots Global Cancer Trial Database for DxFLEX 10C Clinical Study
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Trial Identification
Brief Title: DxFLEX 10C Clinical Study
Official Title: DxFLEX ClearLLab 10C US-IVD Clinical Study Protocol - Clinical Laboratory
Study ID: NCT05467449
Conditions
Interventions
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.
Detailed Description:
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
NeoGenomics Laboratories, Aliso Viejo, California, United States
University of Miami Miller School of Medicine, Miami, Florida, United States
Quest Diagnostics, Lewisville, Texas, United States
PhenoPath Laboratories, PLLC, Seattle, Washington, United States
London Health Sciences Centre, London, Ontario, Canada
Munich Leukemia Laboratory (MLL), Munich, , Germany
Contact Details
Name: Guoyan Cheng, PhD
Affiliation: Beckman Coulter, Inc.
Role: STUDY_DIRECTOR
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