NCT06462768Recruiting
Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis
Neutrophil Extracellular Traps in Systemic Sclerosis
Source: ClinicalTrials.gov · Last updated 17 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 260 (estimated)
- First submitted
- 12 Jun 2024
- Start date
- 27 Nov 2023
- Primary completion date
- 27 Oct 2028
- Lead sponsor
- CHU de Reims
- NCT number
- NCT06462768
What you commit to
- Study type: Observational
- Planned participants: 260
- From 27 Nov 2023 to the primary completion date, 27 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with inflammatory pathology or infectious acute intercurrent pathology in the last 15 days before inclusion
Age
- Patients/Healthy volunteers under 18 years old
Other
- Patients/Healthy volunteers protected by the law
- Patients/Healthy volunteers not consenting to participate to the study after information
- Pregnant or breastfeeding women
Who the study is looking for
- \*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
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Reims Coordinator of this site? Confirm its status | Reims | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.