Critical CareCHEX-DRNCT05546632
Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of Human Leukocyte Antigen - DR Isotype (HLA-DR) Molecules by Flow Cytometry
An observational study of Critical Care, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The expression of mHLA-DR, measured by flow cytometry, is today the reference marker to guide immunostimulatory therapies (IFN-γ) in the most severely immunocompromised patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care
- What is being tested?
- Blood sampling
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2022to 14 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will focus on patients hospitalized in the intensive care unit of the Edouard Herriot hospital in Lyon
Who may be able to join
- Adult patient hospitalized in intensive care unit
- Patient able to consent and having expressed his non-objection (in the case where the patient is aware) OR Patient whose trusted person has given his non-objection (in the case where the patient is not able to consent, example intubated patient)
Who cannot join
- Pregnant women
- Minors
- Persons deprived of their liberty by a judicial or administrative decision
- Persons subject to psychiatric care
- Adults subject to a legal protection measure (guardianship, protection of vulnerable adults)
- Patient who doesn't understand French language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of HLA-DR Molecules by Flow Cytometry
The expression of mHLA-DR, measured by flow cytometry, is today the reference marker to guide immunostimulatory therapies (IFN-γ) in the most severely immunocompromised patients. Nevertheless, pre-analytical constraints (storage of samples at +4°C before analysis) limit the wide use of mHLA-DR in clinical practice (problem of transporting samples to sites with a flow cytometer). Recent studies have shown that samples taken on Cyto-Chex Blood Collection Tubes (BCT) (containing a cell membrane stabilizer) were, for mHLA-DR, stable at room temperature during 72 hours after sampling. The main objective of this study is to compare the expression of mHLA-DR from samples taken simultaneously from standard tubes (EDTA) and new generation Cyto-Chex BCT tubes, to validate using Cyto Chex BCT tube in the clinical practice.
The investigators think that mHLA-DR quantification performed from Cyto-Chex BCT tubes is reliable and similar to quantification performed from EDTA tubes.
- Conditions
- Critical Care
- Being tested
- Blood sampling
- Keywords
- Intensive care unit, HLA-DR, blood sample, Cyto-chex tube, EDTA tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
Patients will have one blood sampling using one EDTA tube and one Cyto-Chex BCT tube, one after the other
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Patients included in this study will have blood sampling using EDTA tube and nex generation Cyto-Chex BCT tubes in order to compare compare the expression of mHLA-DR with these two types of tubes Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of anti-HLA-DR antibodies per cell
The quantity of anti-HLA-DR antibodies per single cell will be assessed in each tube (EDTA and Cyto Chex) using flowcytometry
Measured: The day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start13 Oct 2022
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Claire LUKASZEWICZ, Professor, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546632
- Sponsor's protocol ID
- 69HCL22_0446
- Acronym
- CHEX-DR
- Status last verified
- Jun 2024
- First submitted
- 15 Sep 2022
- Last updated
- 12 Jun 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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of HLA-DR Molecules by Flow Cytometry
- ClinicalTrials.gov ID
- NCT05546632
- Acronym / sponsor ID
- CHEX-DR / 69HCL22_0446
- Conditions
- Critical Care
- Keywords
- Intensive care unit, HLA-DR, blood sample, Cyto-chex tube, EDTA tube
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 21 Sep 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.
The expression of mHLA-DR, measured by flow cytometry, is today the reference marker to guide immunostimulatory therapies (IFN-γ) in the most severely immunocompromised patients. Nevertheless, pre-analytical constraints (storage of samples at +4°C before analysis) limit the wide use of mHLA-DR in clinical practice (problem of transporting samples to sites with a flow cytometer). Recent studies have shown that samples taken on Cyto-Chex Blood Collection Tubes (BCT) (containing a cell membrane stabilizer) were, for mHLA-DR, stable at room temperature during 72 hours after sampling. The main objective of this study is to compare the expression of mHLA-DR from samples taken simultaneously from standard tubes (EDTA) and new generation Cyto-Chex BCT tubes, to validate using Cyto Chex BCT tube in the clinical practice.
The investigators think that mHLA-DR quantification performed from Cyto-Chex BCT tubes is reliable and similar to quantification performed from EDTA tubes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Diagnostic Test: Blood samplingPatients included in this study will have blood sampling using EDTA tube and nex generation Cyto-Chex BCT tubes in order to compare compare the expression of mHLA-DR with these two types of tubes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will focus on patients hospitalized in the intensive care unit of the Edouard Herriot hospital in Lyon
Key inclusion criteria (2 listed)
- Adult patient hospitalized in intensive care unit
- Patient able to consent and having expressed his non-objection (in the case where the patient is aware) OR Patient whose trusted person has given his non-objection (in the case where the patient is not able to consent, example intubated patient)
Key exclusion criteria (6 listed)
- Pregnant women
- Minors
- Persons deprived of their liberty by a judicial or administrative decision
- Persons subject to psychiatric care
- Adults subject to a legal protection measure (guardianship, protection of vulnerable adults)
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 |
|---|---|---|
| Blood samplingPatients will have one blood sampling using one EDTA tube and one Cyto-Chex BCT tube, one after the other | Diagnostic test | Critically ill patients |
Primary outcome
Quantity of anti-HLA-DR antibodies per cell
Time frame: The day of inclusion
The quantity of anti-HLA-DR antibodies per single cell will be assessed in each tube (EDTA and Cyto Chex) using flowcytometry
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 12 Jun 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.
Anne-Claire LUKASZEWICZ, Professor principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care, run by Hospices Civils de Lyon at 1 site in France.
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 2 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 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Quantity of anti-HLA-DR antibodies per cell (time frame: The day of inclusion). 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 12 Jun 2024.