Analysis of Cytokine Expression Pattern in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— SCLEROKINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03537105
• Other study ID #: SCLEROKINE
• Status: Completed
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: September 4, 2019

Study information

• Verified date: April 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 4, 2019
• Est. primary completion date: September 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

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

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (2)

Lead Sponsor	Collaborator
Poitiers University Hospital	University of Poitiers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin IL-34 mRNA expression levels	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)	1 day
Secondary	Immunostainings against IL-34 and other cytokines on skin sections	Immunostainings against IL-34 and other cytokines on skin sections from systemic sclerosis patients versus healthy skins	1 day
Secondary	Protein expression levels of IL-34 and other cytokines by ELISA	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	1 day
Secondary	Skin IL-34 mRNA expression levels of other cytokines	Skin IL-34 mRNA expression levels of other cytokines in patients with systemic sclerosis compared to healthy patients.	1 day