Clinical trial · Observational
DxFLEX 10C Clinical Study
DxFLEX ClearLLab 10C US-IVD Clinical Study Protocol - Clinical Laboratory
NCT05467449CI-TRIAL-00073980completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DxFLEX 10C | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hematologically normal
- description
- Based on immunophenotyping
- interventionNames
- Device: DxFLEX 10C
- label
- Hematologically abnormal
- description
- Based on immunophenotyping
- interventionNames
- Device: DxFLEX 10C
Primary outcomes (1)
- measure
- Flow immunophenotyped normal and abnormal
- timeFrame
- immediately after the analysis
- description
- Based on WHO guidelines for Leukemia \& Lymphoma
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.