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Clinical Trials/NCT03537105
NCT03537105CompletedNot Applicable

Analysis of Cytokine Expression Pattern in Systemic Sclerosis: Study of the Role of Interleukine-34

Poitiers University Hospital1 site in 1 country22 target enrollmentStarted: July 12, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Skin IL-34 mRNA expression levels

Study Overview

Brief Summary

By contrast to other proinflammatory cytokines which are found up-regulated in the skin of patients with psoriasis, atopic dermatitis or systemic sclerosis, IL-34 is the only cytokine that undergoes down-regulation. This finding is interesting regarding the description of IL-34 as an immunosuppressive cytokine. In this study, the expression and the role of interleukin-34 (IL-34) will be investigated in the physiopathology of systemic sclerosis.

Detailed Description

The mechanisms involved in the physiopathology of systemic sclerosis (SSc) are not fully understood, particularly the pattern of cytokine expression in the skin of SSc patients. These cytokines are known to play a central role in the regulation of numerous inflammatory diseases and, among them, IL-34 is the only cytokine which has been found to be down-regulated in other skin inflammatory disorders such psoriasis or atopic dermatitis. IL-34 has been described as an immunosuppressive cytokine, and our preliminary results show that IL-34 is active on fibroblasts, a key cell that undergoes dysfunction in SSc. Thus, we are willing to explore its expression profile in the skin of SSc patients and its potential role in the physiopathology of the disease. For this study, we will analyze IL-34 mRNA levels in the skin and the plasma of SSc patients by comparison to healthy patients. Thirty patients will be included in the Internal Medicine Unit of the CHU de Poitiers during a single visit, in the frame of their medical follow-up, to collect two skin biopsies and 5 ml of blood after obtaining their informed consent. The expression of IL-34 will also be investigated at the protein level by immunostaining on skin sections and by ELISA (skin protein lysates and plasma). Moreover, the expression of other proinflammatory cytokines will be investigated both at the mRNA and protein levels.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age ≥ 18 year-old
  • •Diagnosis of systemic sclerosis according to ACR/EURAL 2013 criteria.
  • •Skin sclerosis reaching an area over finger bases of hands and feet
  • •Free subject, without neither guardianship, wardship nor subordination
  • •Patient with Social Security
  • •Informed and signed consent by the patient after clear and loyal information on the study

Exclusion Criteria

  • •Age < 18 year-old
  • •Patients that do not fit the ACR/EURAL 2013 criteria
  • •Patients under immunosuppressive treatment
  • •Sclerosis limited to fingers of hands and feets.
  • •Patient without Social Security
  • •Pregnant and nursing women

Arms & Interventions

Sclerodermic patients

Experimental

Sclerodermic patients presenting cutaneous fibrosis

Intervention: Skin biopsies (Procedure)

Outcomes

Primary Outcomes

Skin IL-34 mRNA expression levels

Time Frame: 1 day

Skin IL-34 mRNA expression levels (expressed in % of relative expression of GAPDH) in systemic sclerosis patients by comparison with healthy subjects. Skin biopsies are collected at D0 for SSc patients (inclusion day)

Secondary Outcomes

  • Immunostainings against IL-34 and other cytokines on skin sections(1 day)
  • Protein expression levels of IL-34 and other cytokines by ELISA(1 day)
  • Skin IL-34 mRNA expression levels of other cytokines(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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