Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06462768

Neutrophil Extracellular Traps in Different Forms of 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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

Blood sample to quantify and qualify NETosis in vivo and ex vivo after different stimulations.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Analysis of the composition of Neutrophil Extracellular Traps (NETs)

    Time frame: Day 0

    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.

  2. Analysis of the cytokines influencing Neutrophil Extracellular Traps NETs production in vitro

    Time frame: Day 0

    Comparative analysis of the quantity of Neutrophil Extracellular Traps (NETs) generated after stimulation of neutrophils from SSC patients in vitro by differents cytokines

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin DIDIER, Dr.

CONTACT

[email protected]

03.26.83.24.44

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

Neutrophil Extracellular Traps in Systemic Sclerosis

Acronym: NETOSE

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Jun 17, 2024
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.