Systemic SclerosisNETOSENCT06462768
Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis
An observational study of Systemic Sclerosis and Other Connective Tissue Disease, run by CHU de Reims at 1 site in France.
Trial summary
Systemic SClerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to vasculopathy and/or fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis, Other Connective Tissue Disease, Systemic Lupus Erythematosus
- What is being tested?
- Blood sample
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2023to 27 Apr 2029
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1 : Adult with SSc Group 2 : Adult with other connective tissue disease Group 3 : Healthy adult volunteer
Who may be able to join
- For patients of group 1:
- Patients with systemic sclerosis (ACR-EULAR Criteria)
- Patients taking care of in internal medicine or in dermatology department's of the university hospital of Reims
- Patients consenting to participate to the study
- Patients enrolled in the national healthcare insurance program
- For patients of group 2:
Show all 18Show fewer
- Patients with other connective tissue disease (ACR specific-disease criteria)
- Patients taking care of in internal medicine or in dermatology department's of the university hospital of Reims
- Patients consenting to participate to the study
- Patients enrolled in the national healthcare insurance program
- For patients of group 3 (healthy volunteers)
- Patients eligible for blood donation (blood donation regulation criteria of January 11th 2022 decree)
- Patients without medical history of autoimmune systemic or chronic inflammatory systemic disease,
- Patients without current or past neoplasy disease,
- Patients without chronic metabolic pathology
- Patients without treatment by anti inflammatory or corticotherapy for the last 15 days,
- Patients without infectious pathology or inflammatory acute for the last 15 days
- Patients consenting to participate to the study
Who cannot join
- Patients/Healthy volunteers under 18 years old
- Patients/Healthy volunteers protected by the law
- Patients/Healthy volunteers not consenting to participate to the study after information
- Patients with inflammatory pathology or infectious acute intercurrent pathology in the last 15 days before inclusion
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, Pr., 326788472 ext. 33, djolly@chu-reims.fr
About this study
Official title: Neutrophil Extracellular Traps in Systemic Sclerosis
Systemic SClerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to vasculopathy and/or fibrosis. The loss of self-tolerance is believed to be caused by the dysregulation of both innate and adaptive immune systems and may involve Reactive Oxygen Species (ROS).
Neutrophils are potent producers of ROS and may play a role in endothelial cells and fibrobasts dysfunction, as in autoantibodies generation. However, their role in SSC pathogenesis remains to be determined. Recent studies discovered abnormal regulation of Neutrophil Extracellular Traps (NETs) in other auto-immune diseases such as Systemic Lupus Erythematosus (SLE). NETs are web-like structures composed of chromatin backbones and granular molecules. They are released by activated neutrophils through a process called "NETosis". Nets were first described in 2004 as a novel host defense mechanism to trap and kill foreign pathogens. Recent evidence shows that NETs also participate in the pathogenesis of a variety of inflammatory and autoimmune diseases, including SLE.
The investigators recently highlighted this phenomenon in SSc, especially in patients with vascular complications and/or at a early stage of the disease. The investigators will now explore the factors implicated in this dysregulation of NETosis in SSc.
Read the detailed description
This study is designed to assess the role of Neutrophil Extracellular Traps (NETs) in Systemic SClerosis (SSC) as well as to evaluate the correlation between NETs production and NETs composition and the different complications and phenotypes observed in SSC.
100 SSC patients, 30 other connective tissue disease patients and 130 healthy subjects will be recruited. Blood samples will be collected to obtain plasma, serum and polynuclear neutrophils by negative selection.
- Conditions
- Systemic Sclerosis, Other Connective Tissue Disease, Systemic Lupus Erythematosus, Dermatomyositis, ANCA Associated Vasculitis
- Being tested
- Blood sample
- Keywords
- Systemic sclerosis, NETosis, polymorphonuclear neutrophil
- Medical subject headings
- Scleroderma, Systemic, Lupus Erythematosus, Systemic, Dermatomyositis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood sample to quantify and qualify NETosis in vivo and ex vivo after different stimulations.
| Study group | Role | What they receive |
|---|---|---|
| Adult with SSc | Adult with SSc Receives: Other: Blood sample | |
| Other connective tissue disease | Adult with other connective tissue disease Receives: Other: Blood sample | |
| Control | Healthy adult volunteer Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, SLE and healthy controls.
Comparative analysis of the quantity of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, other connective tissue diseases and healthy controls. Neutrophils from SSC, other connective tissue diseases and healthy subjects will be used.
Measured: Day 0
Secondary outcomes (2)
Analysis of the composition of Neutrophil Extracellular Traps (NETs)
Comparative analysis of the composition of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, other connective tissue diseases and healthy controls. Neutrophils from SSC, other connective tissue diseases and healthy subjects will be used.
Measured: Day 0
Analysis of the cytokines influencing Neutrophil Extracellular Traps NETs production in vitro
Comparative analysis of the quantity of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils from SSC patients in vitro by differents cytokines
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start27 Nov 2023
- Primary completion27 Oct 2028 (estimated)
- Study completion27 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462768
- Sponsor's protocol ID
- PO23126
- Acronym
- NETOSE
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Didier K, Giusti D, Le Jan S, Terryn C, Muller C, Pham BN, Le Naour R, Antonicelli FD, Servettaz A. Neutrophil Extracellular Traps Generation Relates with Early Stage and Vascular Complications in Systemic Sclerosis. J Clin Med. 2020 Jul 7;9(7):2136. doi: 10.3390/jcm9072136.
PubMed 32645862
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil Extracellular Traps in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT06462768
- Acronym / sponsor ID
- NETOSE / PO23126
- Conditions
- Systemic Sclerosis, Other Connective Tissue Disease, Systemic Lupus Erythematosus, Dermatomyositis, ANCA Associated Vasculitis
- Keywords
- Systemic sclerosis, NETosis, polymorphonuclear neutrophil
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 27 Oct 2028 (estimated)
- Study completion
- 27 Apr 2029 (estimated)
- First posted
- 17 Jun 2024 (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 SClerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to vasculopathy and/or fibrosis. The loss of self-tolerance is believed to be caused by the dysregulation of both innate and adaptive immune systems and may involve Reactive Oxygen Species (ROS).
Neutrophils are potent producers of ROS and may play a role in endothelial cells and fibrobasts dysfunction, as in autoantibodies generation. However, their role in SSC pathogenesis remains to be determined. Recent studies discovered abnormal regulation of Neutrophil Extracellular Traps (NETs) in other auto-immune diseases such as Systemic Lupus Erythematosus (SLE). NETs are web-like structures composed of chromatin backbones and granular molecules. They are released by activated neutrophils through a process called "NETosis". Nets were first described in 2004 as a novel host defense mechanism to trap and kill foreign pathogens. Recent evidence shows that NETs also participate in the pathogenesis of a variety of inflammatory and autoimmune diseases, including SLE.
The investigators recently highlighted this phenomenon in SSc, especially in patients with vascular complications and/or at a early stage of the disease. The investigators will now explore the factors implicated in this dysregulation of NETosis in SSc.
Detailed description
This study is designed to assess the role of Neutrophil Extracellular Traps (NETs) in Systemic SClerosis (SSC) as well as to evaluate the correlation between NETs production and NETs composition and the different complications and phenotypes observed in SSC.
100 SSC patients, 30 other connective tissue disease patients and 130 healthy subjects will be recruited. Blood samples will be collected to obtain plasma, serum and polynuclear neutrophils by negative selection.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult with SSc | – | Other: Blood sampleAdult with SSc |
| Other connective tissue disease | – | Other: Blood sampleAdult with other connective tissue disease |
| Control | – | Other: Blood sampleHealthy adult volunteer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1 : Adult with SSc Group 2 : Adult with other connective tissue disease Group 3 : Healthy adult volunteer
Key inclusion criteria (18 listed)
- Patients with systemic sclerosis (ACR-EULAR Criteria)
- Patients taking care of in internal medicine or in dermatology department's of the university hospital of Reims
- Patients consenting to participate to the study
- Patients enrolled in the national healthcare insurance program
- Patients with other connective tissue disease (ACR specific-disease criteria)
Key exclusion criteria (5 listed)
- Patients/Healthy volunteers under 18 years old
- Patients/Healthy volunteers protected by the law
- Patients/Healthy volunteers not consenting to participate to the study after information
- Patients with inflammatory pathology or infectious acute intercurrent pathology in the last 15 days before inclusion
- Pregnant or breastfeeding women
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 sampleBlood sample to quantify and qualify NETosis in vivo and ex vivo after different stimulations. | Other | Adult with SSc, Control, Other connective tissue disease |
Primary outcome
Quantification of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, SLE and healthy controls.
Time frame: Day 0
Comparative analysis of the quantity of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, other connective tissue diseases and healthy controls. Neutrophils from SSC, other connective tissue diseases and healthy subjects will be used.
2 secondary outcomes
Analysis of the composition of Neutrophil Extracellular Traps (NETs)
Time frame: Day 0
Analysis of the cytokines influencing Neutrophil Extracellular Traps NETs production in vitro
Time frame: Day 0
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 17 Jun 2024.
- Background: PubMed 32645862Didier K, Giusti D, Le Jan S, Terryn C, Muller C, Pham BN, Le Naour R, Antonicelli FD, Servettaz A. Neutrophil Extracellular Traps Generation Relates with Early Stage and Vascular Complications in Systemic Sclerosis. J Clin Med. 2020 Jul 7;9(7):2136. doi: 10.3390/jcm9072136.
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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.
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 Sclerosis and Other Connective Tissue Disease, run by CHU de Reims 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 18 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 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?
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 Kevin DIDIER, Dr. (03.26.83.24.44, kdidier@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, SLE and healthy controls. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06462768, which also lists 1 linked publication.
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 17 Jun 2024.