NCT02636127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2018

Completed
Last Updated

May 8, 2026

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

December 9, 2015

Last Update Submit

May 4, 2026

Conditions

Scleroderma, Systemic

Outcome Measures

Primary Outcomes (1)

  • blood sample will be done for dosage of Fractalkine in the serum

    12 months

Secondary Outcomes (1)

  • blood sample for functional study of the interactions between T cells and NK cells and / endothelial cells (HMVEC)

    12 months

Study Arms (2)

Systemic Sclerosis (SSc) patient

EXPERIMENTAL

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

Other: blood samples

healthy patient

OTHER

15 healthy patients will be recruited and blood samples will be obtained

Other: blood samples

Interventions

blood samplesOTHER

one blood sample will be done for dosage and role of Fractalkine in the serum. \- Functional study of the interactions between T cells and NK cells and / endothelial cells (HMVEC): immuno mediated endothelial cytotoxicity, endothelial activation and microparticles release by the HMVEC, endothelial progenitor cells analysis and evaluation of the endothelial lysis by fluorescence release.

Systemic Sclerosis (SSc) patienthealthy patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • Benyamine A, Magalon J, Sabatier F, Lyonnet L, Robert S, Dumoulin C, Morange S, Mazodier K, Kaplanski G, Reynaud-Gaubert M, Rossi P, Dignat-George F, Granel B, Paul P. Natural Killer Cells Exhibit a Peculiar Phenotypic Profile in Systemic Sclerosis and Are Potent Inducers of Endothelial Microparticles Release. Front Immunol. 2018 Jul 18;9:1665. doi: 10.3389/fimmu.2018.01665. eCollection 2018.

    PMID: 30072999RESULT

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Brigitte GRANEL, MD

    Assistance Publique Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 21, 2015

Study Start

December 7, 2015

Primary Completion

July 21, 2016

Study Completion

July 8, 2018

Last Updated

May 8, 2026

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)