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Completed

NCT Number: NCT03537105

Analysis of Cytokine Expression Pattern in Systemic Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Poitiers

Poitiers, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin biopsies

Procedure

Two skin biopsies (4mm punch) are performed under local anesthesia at the site of cutaneous inflammation/fibrosis.

Other names: Serum collection

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Collaborators

  • University of Poitiers

Registry information

Official study title

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

Acronym: SCLEROKINE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 25, 2018
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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