Systemic Lupus ErythematosusMDSC-SLENCT05424627
Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2022to 15 Jan 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with active SLE
Who may be able to join
- Active systemic lupus erythematosus (SLEDAI > or = 1)
- Written informed consent
Who cannot join
- Chronic or acute infection
- Other active auto-immune condition
- Active cancer
- Age below 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Involvement of Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus
Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes.
The objectives of this study is to assess the involvement of MDSC in SLE through accurate phenotypical and functional assessment, as well as characterizing their immunometabolic profile, and to identify innovative therapeutic strategies.
Read the detailed description
Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes.
To gain insight into the involvement of MDSC in SLE, both deep phenotypical characterization of MDSC and functional assessment will be performed, as well as immunometabolic characterization. This data will be correlated to the clinical presentation and activity of SLE.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- myeloid derived suppressor cells
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
MDSC percentage among total PBMC
Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
Measured: Baseline
MDSC percentage among total PBMC
Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
Measured: 3 months
MDSC percentage among total PBMC
Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
Measured: 6 months
MDSC percentage among total PBMC
Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
Measured: Between 9 and 24 months if patient experience relapse during follow-up
Secondary outcomes (16)
Serum cytokine levels
pro and anti-inflammatory cytokine levels in serum
Measured: Baseline
Serum cytokine levels
pro and anti-inflammatory cytokine levels in serum
Measured: 3 months
Serum cytokine levels
pro and anti-inflammatory cytokine levels in serum
Measured: 6 months
Serum cytokine levels
pro and anti-inflammatory cytokine levels in serum
Measured: Between 9 and 24 months if patient experience relapse during follow-up
MDSC inflammasome activation
flow cytometry assessment of inflammasome activation within MDSCs
Measured: Baseline
MDSC inflammasome activation
flow cytometry assessment of inflammasome activation within MDSCs
Measured: 3 months
MDSC inflammasome activation
flow cytometry assessment of inflammasome activation within MDSCs
Measured: 6 months
MDSC inflammasome activation
flow cytometry assessment of inflammasome activation within MDSCs
Measured: Between 9 and 24 months if patient experience relapse during follow-up
Immunometabolic profile
flow cytometry assessment of metabolic profile of MDSCs
Measured: Baseline
Immunometabolic profile
flow cytometry assessment of metabolic profile of MDSCs
Measured: 3 months
Immunometabolic profile
flow cytometry assessment of metabolic profile of MDSCs
Measured: 6 months
Immunometabolic profile
flow cytometry assessment of metabolic profile of MDSCs
Measured: Between 9 and 24 months if patient experience relapse during follow-up
MDSC subpopulations percentage
flow cytometry assessment of known (Monocytic, Granulocytic, Early-stage) and unknow subpopulations of MDSC
Measured: Baseline
MDSC subpopulations percentage
flow cytometry assessment of known (Monocytic, Granulocytic, Early-stage) and unknow subpopulations of MDSC
Measured: 3 months
MDSC subpopulations percentage
flow cytometry assessment of known (Monocytic, Granulocytic, Early-stage) and unknow subpopulations of MDSC
Measured: 6 months
MDSC subpopulations percentage
flow cytometry assessment of known (Monocytic, Granulocytic, Early-stage) and unknow subpopulations of MDSC
Measured: Between 9 and 24 months if patient experience relapse during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start15 Jul 2022 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas MOULINET, Central Hospital, Nancy, France
- Investigators
- Thomas Moulinet, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424627
- Sponsor's protocol ID
- 2022-A00601-42
- Acronym
- MDSC-SLE
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 21 Jun 2022
- 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 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05424627
- Acronym / sponsor ID
- MDSC-SLE / 2022-A00601-42
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- myeloid derived suppressor cells
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 21 Jun 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.
Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes.
The objectives of this study is to assess the involvement of MDSC in SLE through accurate phenotypical and functional assessment, as well as characterizing their immunometabolic profile, and to identify innovative therapeutic strategies.
Detailed description
Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes.
To gain insight into the involvement of MDSC in SLE, both deep phenotypical characterization of MDSC and functional assessment will be performed, as well as immunometabolic characterization. This data will be correlated to the clinical presentation and activity of SLE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with active SLE
Key inclusion criteria (2 listed)
- Active systemic lupus erythematosus (SLEDAI > or = 1)
- Written informed consent
Key exclusion criteria (4 listed)
- Chronic or acute infection
- Other active auto-immune condition
- Active cancer
- Age below 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MDSC percentage among total PBMC
Time frame: Baseline
Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
MDSC percentage among total PBMC
Time frame: 3 months
Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
MDSC percentage among total PBMC
Time frame: 6 months
Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
MDSC percentage among total PBMC
Time frame: Between 9 and 24 months if patient experience relapse during follow-up
Correlation between MDSC percentage among total PBMC and Clinical activity of SLE (SLEDAI score)
16 secondary outcomes
Serum cytokine levels
Time frame: Baseline
Serum cytokine levels
Time frame: 3 months
Serum cytokine levels
Time frame: 6 months
Serum cytokine levels
Time frame: Between 9 and 24 months if patient experience relapse during follow-up
MDSC inflammasome activation
Time frame: Baseline
MDSC inflammasome activation
Time frame: 3 months
MDSC inflammasome activation
Time frame: 6 months
MDSC inflammasome activation
Time frame: Between 9 and 24 months if patient experience relapse during follow-up
Immunometabolic profile
Time frame: Baseline
Immunometabolic profile
Time frame: 3 months
Immunometabolic profile
Time frame: 6 months
Immunometabolic profile
Time frame: Between 9 and 24 months if patient experience relapse during follow-up
MDSC subpopulations percentage
Time frame: Baseline
MDSC subpopulations percentage
Time frame: 3 months
MDSC subpopulations percentage
Time frame: 6 months
MDSC subpopulations percentage
Time frame: Between 9 and 24 months if patient experience relapse during follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: No
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RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
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RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
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A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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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.
Thomas Moulinet principal investigator
CHRU de Nancy
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 Systemic Lupus Erythematosus, run by Central Hospital, Nancy, France 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 4 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: opening soon, as of the sponsor's last update on 21 Jun 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Moulinet, MD (+33383155304, t.moulinet@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDSC percentage among total PBMC (time frame: Baseline). The study lists 4 primary outcomes in all. 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 21 Jun 2022.