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Analysis of Cytokine Expression Pattern in Systemic Sclerosis (SCLEROKINE)

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ClinicalTrials.gov Identifier: NCT03537105
Recruitment Status : Not yet recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
University of Poitiers
Information provided by (Responsible Party):
Poitiers University Hospital

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Procedure: Skin biopsies Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Sclerodermic patients
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Analysis of Cytokine Expression Pattern in Systemic Sclerosis: Study of the Role of Interleukine-34
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Scleroderma

Arm Intervention/treatment
Experimental: Sclerodermic patients
Sclerodermic patients presenting cutaneous fibrosis
Procedure: Skin biopsies
Two skin biopsies (4mm punch) are performed under local anesthesia at the site of cutaneous inflammation/fibrosis.
Other Name: Serum collection




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Immunostainings against IL-34 and other cytokines on skin sections [ Time Frame: 1 day ]
    Immunostainings against IL-34 and other cytokines on skin sections from systemic sclerosis patients versus healthy skins

  2. Protein expression levels of IL-34 and other cytokines by ELISA [ Time Frame: 1 day ]
    Protein expression levels of IL-34 and other cytokines by ELISA (quantitative study) in plasma and lysates of skin biopsies from systemic sclerosis patients versus

  3. Skin IL-34 mRNA expression levels of other cytokines [ Time Frame: 1 day ]
    Skin IL-34 mRNA expression levels of other cytokines in patients with systemic sclerosis compared to healthy patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537105


Contacts
Contact: Pascal Roblot, MD (0)5.49.44.44.22 ext +33 pascal.roblot@univ-poitiers.fr
Contact: Mathieu Puyade, MD (0)5 49 44 40 04 ext +33 mathieu.puyade@univ-poitiers.fr

Sponsors and Collaborators
Poitiers University Hospital
University of Poitiers

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03537105     History of Changes
Other Study ID Numbers: SCLEROKINE
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poitiers University Hospital:
cytokine
skin inflammation

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases