NCT06462768 Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis
| NCT ID | NCT06462768 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Reims |
| Condition | Systemic Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 260 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2028-10-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 260 participants in total. It began in 2023-11-27 with a primary completion date of 2028-10-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: \*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 Exclusion Criteria for patients of all groups: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06462768 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06462768 currently recruiting?
Yes, NCT06462768 is actively recruiting participants. Contact the research team at kdidier@chu-reims.fr for enrollment information.
Where is the NCT06462768 trial being conducted?
This trial is being conducted at Reims, France.
Who is sponsoring the NCT06462768 clinical trial?
NCT06462768 is sponsored by CHU de Reims. The trial plans to enroll 260 participants.