ClinicalTrials.gov record NCT06462768

Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Neutrophil Extracellular Traps in Systemic Sclerosis

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Jun 17, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study collects blood from adults with systemic sclerosis, adults with other connective tissue diseases, and healthy volunteers. Lab tests will measure how many neutrophil extracellular traps (NETs) form and what they contain, and will study factors that influence NET production. Planned enrollment is about 100 systemic sclerosis patients, 30 other connective tissue disease patients, and 130 healthy volunteers.

What it is studying. The study is testing whether NETs (neutrophil extracellular traps) differ in amount or composition between people with systemic sclerosis, people with other connective tissue diseases, and healthy volunteers, and whether serum factors or cytokines influence NET production.

What the researchers hope to learn. To assess the role of NETs in systemic sclerosis; to compare NET production and composition across systemic sclerosis, other connective tissue diseases, and healthy controls; to analyze cytokines and serum factors that influence NET production; and to explore links between NET features and disease complications or phenotypes in systemic sclerosis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • Blood sample

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you join, you will be asked to give one or more blood samples. The blood will be used to separate plasma, serum, and neutrophils (polymorphonuclear cells) so researchers can test neutrophil extracellular trap (NET) production and composition and study cytokine effects in the lab. You will be asked to provide informed consent; the record does not describe other visits, treatments, or participant services.

How the study is structured. A prospective observational study that collects a blood sample (Day 0) from three groups—about 100 systemic sclerosis patients, 30 other connective tissue disease patients, and 130 healthy volunteers—and performs lab experiments using participants' neutrophils and serum to measure and compare NET formation and composition.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on polymyositis

This trial is also listed on this site under dermatomyositis.

Clinical trials55 trials listed for polymyositisEvery trial the registry lists for polymyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in polymyositis researchLatest monthly update: September 2026. Includes: CD4 count risk. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Nov 27, 2023
Primary completion
Oct 27, 2028 (estimated)
Study completion
Apr 27, 2029 (estimated)
Target enrollment
260 participants (estimated)
Last updated on registry
Jun 17, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
CHU de Reims

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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