Analysis of Cytokine Expression Pattern in Systemic Sclerosis

NCT ID: NCT03537105

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2019-09-04

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.

Conditions

Systemic Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sclerodermic patients

Sclerodermic patients presenting cutaneous fibrosis

Group Type: EXPERIMENTAL

Skin biopsies

Intervention Type: PROCEDURE

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

Interventions

Skin biopsies

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

Intervention Type: PROCEDURE

Other Intervention Names

Serum collection

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Poitiers

OTHER

Sponsor Role: collaborator

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-François Jégou, PhD

Role: STUDY_DIRECTOR

University of Poitiers

Locations

CHU de Poitiers

Poitiers, , France

Countries

France

Other Identifiers

SCLEROKINE

Identifier Type: -

Identifier Source: org_study_id