Hematologic MalignancyNCT05819762
Evaluation of ClearLLab LS Screening Panel
An observational study of Hematologic Malignancy and Hematologic Neoplasms, run by Beckman Coulter, Inc. at 4 sites in China.
Trial summary
This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematologic Malignancy, Hematologic Neoplasms, Hematologic Diseases
- What is being tested?
- Flow Cytometry
- How many people
- 831 participants
- Where
- 4 sitesChina
- Study dates
- 25 May 2023to 18 Nov 2024
- How long will I take part?
- 1 Month
- 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: All subjects of any ethnicity, age and racial background will be included
Who may be able to join
- Residual whole blood, bone marrow, or lymph node tissue samples from subjects with hematologic tumor-related symptoms and/or signs that are clinically recommended for Flow Cytometry Immunophenotyping
Who cannot join
- Specimens and/or spent samples that are visibly hemolyzed
- Specimens and/or spent samples that are visibly clotted
- Specimens and/or spent samples collected in Ethylene Diamine Tetraacetic Acid (EDTA) anticoagulant older than 24 hours from time of collection
- Specimens and/or spent samples collected in Heparin or Acid Citrate-Dextrose (ACD) anticoagulant older than 48 hours from time of collection
- Samples with insufficient volume to complete the protocol tests
- Samples from subjects with known myeloid malignancies or multiple myeloma
Trial locations and contacts
4 sites in 1 country.
China4 sites
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin
Tongji Hospital
Wuhan, Hubei
About this study
Official title: Evaluation of ClearLLab LS Screening Panel for the Diagnosis of Hematological Malignancies
This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies.
Read the detailed description
This study aims to evaluate the clinical accuracy of ClearLLab LS screening panel in the diagnosis of hematologic malignancies. The residual specimens, which from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematologic diseases work-up, will be tested by ClearLLab LS screening panel. ClearLLab LS screening panel is CE-IVD marked immunophenotyping reagents under the European Union (EU) regulation, and this study is aimed to validate its clinical performance in Chinese population.
- Being tested
- Flow Cytometry
- Medical subject headings
- Hematologic Neoplasms, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow CytometryDiagnostic test
Immunophenotyping of residual clinical samples tested with ClearLLab LS screening panel on a specified Flow Cytometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy: sensitivity and specificity
Diagnostic accuracy measured as sensitivity and specificity of ClearLLab LS screening panel in identifying hematological malignancies and non-malignancies compared with the clinical criteria (WHO guidelines)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start25 May 2023
- Primary completion15 Oct 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic 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
- 831 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute of Hematology & Blood Diseases Hospital, China, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Tongji Hospital
- Responsible party
- Sponsor
- Investigators
- China Clinical Affaris, Study director, Beckman Coulter, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819762
- Sponsor's protocol ID
- CHN186
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ClearLLab LS Screening Panel for the Diagnosis of Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05819762
- Acronym / sponsor ID
- CHN186
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Institute of Hematology & Blood Diseases Hospital, China, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Tongji Hospital
- Study start
- 25 May 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 19 Apr 2023 (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.
This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies.
Detailed description
This study aims to evaluate the clinical accuracy of ClearLLab LS screening panel in the diagnosis of hematologic malignancies. The residual specimens, which from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematologic diseases work-up, will be tested by ClearLLab LS screening panel. ClearLLab LS screening panel is CE-IVD marked immunophenotyping reagents under the European Union (EU) regulation, and this study is aimed to validate its clinical performance in Chinese population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects of any ethnicity, age and racial background will be included
Key inclusion criteria (1 listed)
- Residual whole blood, bone marrow, or lymph node tissue samples from subjects with hematologic tumor-related symptoms and/or signs that are clinically recommended for Flow Cytometry Immunophenotyping
Key exclusion criteria (6 listed)
- Specimens and/or spent samples that are visibly hemolyzed
- Specimens and/or spent samples that are visibly clotted
- Specimens and/or spent samples collected in Ethylene Diamine Tetraacetic Acid (EDTA) anticoagulant older than 24 hours from time of collection
- Specimens and/or spent samples collected in Heparin or Acid Citrate-Dextrose (ACD) anticoagulant older than 48 hours from time of collection
- Samples with insufficient volume to complete the protocol tests
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 |
|---|---|---|
| Flow CytometryImmunophenotyping of residual clinical samples tested with ClearLLab LS screening panel on a specified Flow Cytometry | Diagnostic test | – |
Primary outcome
Diagnostic accuracy: sensitivity and specificity
Time frame: Baseline
Diagnostic accuracy measured as sensitivity and specificity of ClearLLab LS screening panel in identifying hematological malignancies and non-malignancies compared with the clinical criteria (WHO guidelines)
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 4 Dec 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.
China Clinical Affaris study director
Beckman Coulter, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancy and Hematologic Neoplasms, run by Beckman Coulter, Inc. at 4 sites in China.
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 1 inclusion and 6 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 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
Diagnostic accuracy: sensitivity and specificity (time frame: Baseline). 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 4 Dec 2024.