Clinical trial NCT03537105: Analysis of Cytokine Expression Pattern in Systemic Sclerosis
Official title: Analysis of Cytokine Expression Pattern in Systemic Sclerosis: Study of the Role of Interleukine-34
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Keywords: cytokine
skin inflammation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: University of Poitiers
First posted: 2018-05-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sclerodermic patients
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Skin IL-34 mRNA expression levels
timeFrame: 1 day
Secondary outcomes:
measure: Immunostainings against IL-34 and other cytokines on skin sections
timeFrame: 1 day
measure: Protein expression levels of IL-34 and other cytokines by ELISA
timeFrame: 1 day
measure: Skin IL-34 mRNA expression levels of other cytokines
timeFrame: 1 day
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
affiliation: University of Poitiers
name: Jean-François Jégou, PhD
role: STUDY_DIRECTOR
References: