search
Back to results

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

Primary Purpose

Scleroderma, Systemic

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Scleroderma, Systemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Systemic Sclerosis (SSc) patient

healthy patient

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 9, 2015
Last Updated
September 5, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
search

1. Study Identification

Unique Protocol Identification Number
NCT02636127
Brief Title
Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis
Official Title
Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 7, 2015 (Actual)
Primary Completion Date
July 21, 2016 (Actual)
Study Completion Date
July 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Systemic Sclerosis (SSc) patient
Arm Type
Experimental
Arm Description
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
Arm Title
healthy patient
Arm Type
Other
Arm Description
15 healthy patients will be recruited and blood samples will be obtained
Intervention Type
Other
Intervention Name(s)
blood samples
Intervention Description
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.
Primary Outcome Measure Information:
Title
blood sample will be done for dosage of Fractalkine in the serum
Time Frame
12 months
Secondary Outcome Measure Information:
Title
blood sample for functional study of the interactions between T cells and NK cells and / endothelial cells (HMVEC)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte GRANEL, MD
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs