Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis

Not Applicable

Completed

• Conditions: Scleroderma, Systemic
• Interventions: Other: blood samples

• Registration Number: NCT02636127
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Systemic Sclerosis (SSc) is an auto-immune systemic disease characterized by vascular damage, cutaneous and visceral fibrosis and a dysimmune condition.

Therapies in this disease remain insufficient and the complications resulting from organs involvement lead to strong morbi-mortality.The dermic infiltrate of the patients includes a strong proportion of Tcells. T cells and Natural Killer (NK) cells are potentially involved in the vascular damage of the SSc. However mechanisms at the onset of this endothelial cytotoxicity and its impact on the capacities of regeneration of the endothelial tissue remain poorly understood. Fractalkine is at the same time an endothelial membrane-bound adhesion molecule and a chemokine which is able to bind CX3CR1 expressed by the immune populations. The purpose of the project is to define the role displayed by cytotoxic, circulating immune populations of SSc patients in endothelial cytotoxicity as well as the role of the axis Fractalkine / CX3CR1 in mediating the interactions between the immune cytotoxic cells and the endothelium.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-07
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-21
• Primary Completion: 2016-07-21
• Study Completion: 2018-07-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients affected by SSc of more than 18 years
• Healthy patients

Exclusion Criteria

• Impossibility to take some blood
• Current infection
• Ongoing cancer
• chemotherapy or a current radiotherapy
• pregnant or breast-feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systemic Sclerosis (SSc) patient	blood samples	15 patients whose diagnosis of SSc is made according to the revised ACR/EULAR ( American College of Rheumatology ) criteria 2013 will be recruited and blood samples will be obtained
healthy patient	blood samples	15 healthy patients will be recruited and blood samples will be obtained

Primary Outcome Measures

Name	Time	Method
blood sample will be done for dosage of Fractalkine in the serum	12 months

Secondary Outcome Measures

Name	Time	Method
blood sample for functional study of the interactions between T cells and NK cells and / endothelial cells (HMVEC)	12 months

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France