Hematological MalignancyNCT05467449
DxFLEX 10C Clinical Study
An observational study of Hematological Malignancy, run by Beckman Coulter, Inc. at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematological Malignancy
- What is being tested?
- DxFLEX 10C
- Type of treatment
- Medical device
- How many people
- 527 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 12 Apr 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Intended L\&L population
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
NeoGenomics Laboratories
Aliso Viejo, California, 92656
Quest Diagnostics
Lewisville, Texas, 75067
University of Miami Miller School of Medicine
Miami, Florida, 33136
PhenoPath Laboratories, PLLC
Seattle, Washington, 98134
About this study
Official title: DxFLEX ClearLLab 10C US-IVD Clinical Study Protocol - Clinical Laboratory
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
- Hematological Malignancy
- Being tested
- DxFLEX 10C
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DxFLEX 10CDevice
A device combining flow cytometry and reagents for immunophenotyping analysis
| Study group | Role | What they receive |
|---|---|---|
| Hematologically normal | Based on immunophenotyping Receives: Device: DxFLEX 10C | |
| Hematologically abnormal | Based on immunophenotyping Receives: Device: DxFLEX 10C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow immunophenotyped normal and abnormal
Based on WHO guidelines for Leukemia \& Lymphoma
Measured: immediately after the analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start12 Apr 2022
- Primary completion31 May 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guoyan Cheng, PhD, Study director, Beckman Coulter, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467449
- Sponsor's protocol ID
- C76895
- Status last verified
- Feb 2024
- First submitted
- 15 Jul 2022
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DxFLEX ClearLLab 10C US-IVD Clinical Study Protocol - Clinical Laboratory
- ClinicalTrials.gov ID
- NCT05467449
- Acronym / sponsor ID
- C76895
- Conditions
- Hematological Malignancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hematologically normal | – | Device: DxFLEX 10CBased on immunophenotyping |
| Hematologically abnormal | – | Device: DxFLEX 10CBased on immunophenotyping |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Intended L\&L population
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DxFLEX 10CA device combining flow cytometry and reagents for immunophenotyping analysis | Device | Hematologically abnormal, Hematologically normal |
Primary outcome
Flow immunophenotyped normal and abnormal
Time frame: immediately after the analysis
Based on WHO guidelines for Leukemia \& Lymphoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoyan Cheng, PhD study director
Beckman Coulter, Inc.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancy, run by Beckman Coulter, Inc. at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow immunophenotyped normal and abnormal (time frame: immediately after the analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.