Neutrophil Extracellular Traps Generation Relates with Early Stage and Vascular Complications in Systemic Sclerosis.
Kevin Didier, Delphine Giusti, Sebastien Le Jan...
https://pubmed.ncbi.nlm.nih.gov/32645862Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID06462768
Neutrophil Extracellular Traps in Systemic Sclerosis Observational Study
Led by CHU de Reims · Updated on 2024-06-17
260
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Systemic Sclerosis (SSc) is a disease affecting the skin and organs, involving immune system dysfunction and overproduction of autoantibodies. Researchers are studying the role of Neutrophil Extracellular Traps (NETs), which are web-like structures released by neutrophils during "NETosis," in SSc and their connection to disease complications and different forms of the condition. The study also compares NETs in SSc with other connective tissue diseases and healthy individuals. The study will include 100 SSc patients, 30 patients with other connective tissue diseases, and 130 healthy volunteers. Participants will provide blood samples to measure and analyze NETs production and composition. This observational study collects plasma, serum, and neutrophils to explore how NETs relate to disease features and immune responses. Participants will have blood drawn on the study day to assess NETs quantity and composition, as well as cytokines influencing NETs production. The primary outcome is measuring NETs generated after stimulation of neutrophils in vitro. Secondary outcomes include detailed analysis of NETs components and factors affecting their production. The study involves no treatment and lasts for the duration of sample and data collection on the enrollment day.
CONDITIONS
Brief Title
Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients with systemic sclerosis meeting ACR-EULAR criteria
- Patients with other connective tissue diseases meeting ACR-specific criteria
- Patients under care in the internal medicine or dermatology departments of the University Hospital of Reims
- Patients consenting to participate in the study
- Patients enrolled in the national healthcare insurance program
- Healthy volunteers eligible for blood donation according to regulations
- Healthy volunteers without autoimmune systemic or chronic inflammatory diseases
- Healthy volunteers without current or past cancer
- Healthy volunteers without chronic metabolic diseases
- Healthy volunteers not treated with anti-inflammatory or corticosteroids in the last 15 days
- Healthy volunteers without acute infectious or inflammatory illness in the last 15 days
You will not qualify if you...
- Individuals under 18 years old
- Individuals protected by law
- Individuals not consenting to participate after information
- Individuals with acute inflammatory or infectious illnesses in the 15 days before inclusion
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - 1 day
Blood samples are collected to analyze Neutrophil Extracellular Traps (NETs) and related components.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 5 years
Participants are observed to assess correlations between NETs and different complications and phenotypes in Systemic Sclerosis and other connective tissue diseases.
Trial Site Locations
Total: 1 location
1
Chu Reims
Reims, France, 51092
Actively Recruiting
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Research Team
K
Kevin DIDIER, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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