Analysis of Cytokine Expression Pattern in Systemic Sclerosis
SCLEROKINE
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 25, 2018
CompletedStudy Start
First participant enrolled
July 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2019
CompletedApril 21, 2020
April 1, 2020
1.1 years
May 15, 2018
April 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Immunostainings against IL-34 and other cytokines on skin sections
1 day
Protein expression levels of IL-34 and other cytokines by ELISA
1 day
Skin IL-34 mRNA expression levels of other cytokines
1 day
Study Arms (1)
Sclerodermic patients
EXPERIMENTALSclerodermic patients presenting cutaneous fibrosis
Interventions
Two skin biopsies (4mm punch) are performed under local anesthesia at the site of cutaneous inflammation/fibrosis.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Poitiers University Hospitallead
- University of Poitierscollaborator
Study Sites (1)
CHU de Poitiers
Poitiers, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean-François Jégou, PhD
University of Poitiers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2018
First Posted
May 25, 2018
Study Start
July 12, 2018
Primary Completion
September 4, 2019
Study Completion
September 4, 2019
Last Updated
April 21, 2020
Record last verified: 2020-04