Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis
NETOSE
1 other identifier
observational
260
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 27, 2023
CompletedFirst Submitted
Initial submission to the registry
June 12, 2024
CompletedFirst Posted
Study publicly available on registry
June 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 27, 2029
June 17, 2024
June 1, 2024
4.9 years
June 12, 2024
June 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 0
Secondary Outcomes (2)
Analysis of the composition of Neutrophil Extracellular Traps (NETs)
Day 0
Analysis of the cytokines influencing Neutrophil Extracellular Traps NETs production in vitro
Day 0
Study Arms (3)
Adult with SSc
Adult with SSc
Other connective tissue disease
Adult with other connective tissue disease
Control
Healthy adult volunteer
Interventions
Blood sample to quantify and qualify NETosis in vivo and ex vivo after different stimulations.
Eligibility Criteria
Group 1 : Adult with SSc Group 2 : Adult with other connective tissue disease Group 3 : Healthy adult volunteer
You may qualify if:
- \*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:
- 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
- +3 more criteria
You may not qualify if:
- 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
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Chu Reims
Reims, 51092, France
Related Publications (1)
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.
PMID: 32645862BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2024
First Posted
June 17, 2024
Study Start
November 27, 2023
Primary Completion (Estimated)
October 27, 2028
Study Completion (Estimated)
April 27, 2029
Last Updated
June 17, 2024
Record last verified: 2024-06