Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis. (SCLERO-LB)
Primary Purpose
Scleroderma, Systemic
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
skin biopsy
Blood punction
Sponsored by
About this trial
This is an interventional basic science trial for Scleroderma, Systemic focused on measuring systemic sclerosis, B lymphocyte
Eligibility Criteria
Inclusion Criteria:
patients
- systemic sclerosis according to ACR-EULAR 2013
- written consent
- available insurance
Healthy "blood" and healthy "biopsy" controls
- written consent
- available insurance
Exclusion Criteria:
patients
- overlap with other connective tissue diseases
- immunosuppressants in the past 12 months
- corticosteroids ≥10mg/d
- pregnancy or breast feeding
Healthy "blood" and healthy "biopsy" controls
- systemic sclerosis according to ACR-EULAR 2013
- another connective tissue diseases
- immunosuppressants in the past 12 months
- corticosteroids ≥10mg/d
- pregnancy or breast feeding
- With dysimmune inflammatory diseases (except thyroiditis)
- Presenting an infection in progress or within the previous 15 days
Sites / Locations
- Hôpital Claude Huriez, CHURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
patient with Scs
healthy subject
Arm Description
patients with SSc, (10 diffuse forms and 20 limited forms)
Outcomes
Primary Outcome Measures
Fibroblast transcriptomic : myofibroblast signature
expression of alpha Smooth Muscle Actin
Secondary Outcome Measures
Fibroblast transcriptomic
expression of COL1A1, COL1A2, COL3A1 by quantitative RT-PCR
Difference in collagen infiltration by PicroSirius red staining between the skin biopsies of the two groups
Difference in the inflammatory infiltrate by immunohistological markings between the skin biopsies of the two groups
Full Information
NCT ID
NCT03559465
First Posted
June 5, 2018
Last Updated
January 17, 2023
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT03559465
Brief Title
Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.
Acronym
SCLERO-LB
Official Title
Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
B Lymphocytes are thought to play an important role in the pathophysiology of systemic sclerosis. In this study, the profibrosing role of B lymphocytes of patients with systemic sclerosis will be evaluated.
Detailed Description
B Lymphocytes of patients with systemic sclerosis will be assessed in term of interaction with fibroblasts from patients with systemic sclerosis and compared to healthy controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic
Keywords
systemic sclerosis, B lymphocyte
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient with Scs
Arm Type
Experimental
Arm Description
patients with SSc, (10 diffuse forms and 20 limited forms)
Arm Title
healthy subject
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
skin biopsy
Intervention Description
A skin biopsy will be performed in 10 patients in the form of 2 punches of 5 mm in the injured area in aseptic condition with a Rodnan score.
In this study, 10 skin biopsies are needed, and will be performed on the first 10 patients accepting this biopsy.
Intervention Type
Other
Intervention Name(s)
Blood punction
Intervention Description
1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of B lymphocyte
Primary Outcome Measure Information:
Title
Fibroblast transcriptomic : myofibroblast signature
Description
expression of alpha Smooth Muscle Actin
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Fibroblast transcriptomic
Description
expression of COL1A1, COL1A2, COL3A1 by quantitative RT-PCR
Time Frame
36 months
Title
Difference in collagen infiltration by PicroSirius red staining between the skin biopsies of the two groups
Time Frame
36 months
Title
Difference in the inflammatory infiltrate by immunohistological markings between the skin biopsies of the two groups
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients
systemic sclerosis according to ACR-EULAR 2013
written consent
available insurance
Healthy "blood" and healthy "biopsy" controls
written consent
available insurance
Exclusion Criteria:
patients
overlap with other connective tissue diseases
immunosuppressants in the past 12 months
corticosteroids ≥10mg/d
pregnancy or breast feeding
Healthy "blood" and healthy "biopsy" controls
systemic sclerosis according to ACR-EULAR 2013
another connective tissue diseases
immunosuppressants in the past 12 months
corticosteroids ≥10mg/d
pregnancy or breast feeding
With dysimmune inflammatory diseases (except thyroiditis)
Presenting an infection in progress or within the previous 15 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Launay, MD,PhD
Phone
3 20 44 42 95
Ext
+33
Email
david.launay@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Launay, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Claude Huriez, CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Launay, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.
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