- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03374618
Neutrophil Extracellular Traps in Systemic Sclerosis (NET-SSC)
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.
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study is designed to assess the role of neutrophil extracellular traps (NETs) in systemic sclerosis as well as to evaluate the correlation between NETs production and NETs composition and the different complications and phenotypes observed in SSC.
30 SSC patients, 30 SLE patients and 60 healthy subjects will be recruited. Blood samples will be collected to obtain plasma, serum and polynuclear neutrophils by negative selection.
- The main aim of the study is to evaluate the quantity of NETs induced by serum from SSc patients on neutrophils from either healthy or SSC patients in vitro. The quantity of NETs produced by different populations of neutrophils in contact with sera from SSC will be compared with those produced by the same different populations of neutrophils in contact with sera from SLE, and healthy subjects (two control populations).
Other objectives:
- To assess the composition of the NETs produced by different populations of neutrophils exposed to serum from SSC, SLE and healthy subjects.
- To correlate the quantity and the composition of NETS with clinical phenotype in SSc
- To assess the role of serum cytokines in Nets production in SSC.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Amélie SERVETTAZ
- Numero di telefono: +33 032683269
- Email: aservettaz@chu-reims.fr
Backup dei contatti dello studio
- Nome: Coralie BARBE
- Email: cbarbe@chu-reims.fr
Luoghi di studio
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Reims, Francia
- Reclutamento
- Damien JOLLY
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Contatto:
- Amélie SERVETTAZ
- Email: aservettaz@chu-reims.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: systemic lupus erythematosus
adult with systemic lupus erythematosus
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Blood sample to quantify and qualify netosis in vivo and ex vivo after different stimulations in SSC, SLA and healthy controls
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Sperimentale: systemic sclerosis
adult with systemic sclerosis
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Blood sample to quantify and qualify netosis in vivo and ex vivo after different stimulations in SSC, SLA and healthy controls
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Altro: healthy volunteers
healthy volunteer (adult)
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Blood sample to quantify and qualify netosis in vivo and ex vivo after different stimulations in SSC, SLA and healthy controls
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Quantification of neutrophil extracellular traps (NETs) generated after stimulation of neutrophils in vitro by serum from SSC, SLE and healthy controls.
Lasso di tempo: Day 0
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Analysis of the composition of neutrophil extracellular traps
Lasso di tempo: Day 0
|
Comparative analysis of the composition 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
|
Analysis of the cytokines influencing NETs production in vitro
Lasso di tempo: 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
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Day 0
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PO17014
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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