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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
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Scleroderma, Systemic focused on measuring systemic sclerosis, B lymphocyte

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 5, 2018
Last Updated
January 17, 2023
Sponsor
University Hospital, Lille
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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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