Neutrophil Extracellular Traps in Systemic Sclerosis

NCT03374618 | Completed

• 1 other identifier: PO17014
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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. We hypothesis that this phenomenon could be dysregulated in SSC as in SLE and could play a prominent role in the induction of autoimmunity, as well as in the induction and perpetuation of organ damages.

Conditions

Systemic Lupus Erythematosus; Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Quantification of neutrophil extracellular traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, SLE and healthy controls.

  Comparative analysis of the quantity of neutrophil extracellular traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, SLE and healthy controls. Neutrophils from SSC, SLE and healthy subjects will be used.

  Day 0

Secondary Outcomes (2)

• Analysis of the composition of neutrophil extracellular traps

  Day 0

• Analysis of the cytokines influencing NETs production in vitro

  Day 0

Study Arms (3)

systemic lupus erythematosus

EXPERIMENTAL

adult with systemic lupus erythematosus

Other: Blood sample

systemic sclerosis

EXPERIMENTAL

adult with systemic sclerosis

Other: Blood sample

healthy volunteers

OTHER

healthy volunteer (adult)

Other: Blood sample

Interventions

Blood sample OTHER

Blood sample to quantify and qualify netosis in vivo and ex vivo after different stimulations in SSC, SLA and healthy controls

healthy volunteers; systemic lupus erythematosus; systemic sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• for patients of arm 1:
• patients with systemic lupus erythematosus
• patients consenting to participate to the study
• patients enrolled in the national healthcare insurance program
• for patients of arm 2:
• patients with systemic sclerosis
• patients consenting to participate to the study
• patients enrolled in the national healthcare insurance program
• For patients of arm 3 (healthy volunteers)
• Patients without Chronic inflammatory systemic disease
• Patients without Current or past neoplasy,
• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Scleroderma, Systemic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: December 15, 2017
• Study Start: February 23, 2018
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

FR (1)