Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease (G4-FH)
Primary Purpose
IgG4-related Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
extra blood draw samples
Sponsored by
About this trial
This is an interventional prevention trial for IgG4-related Disease
Eligibility Criteria
Inclusion Criteria:
- IgG4-related disease patients or
- Sjogren syndrome patients or
- Healthy subjects
Exclusion Criteria:
- Presence of autoimmune or inflammatory associated disease
- Age less than 18 years
Sites / Locations
- APHM
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
IgG4-related disease
Sjögren syndrome
Healthy controls
Arm Description
Subjects suffering from IgG4-related disease
Subjects suffering from Sjôgren syndrome
Healthy subjects
Outcomes
Primary Outcome Measures
Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood
Secondary Outcome Measures
Full Information
NCT ID
NCT02899039
First Posted
September 2, 2016
Last Updated
July 27, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02899039
Brief Title
Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease
Acronym
G4-FH
Official Title
Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 17, 2012 (undefined)
Primary Completion Date
May 4, 2015 (Actual)
Study Completion Date
May 7, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
IgG4-related disease is a rare and very recently identified pathology, whose frequency is certainly underestimated.
The clinical presentation varies among affected organs, and most often, patients have at least three organ damage.
These organs exhibit tissue infiltration mononuclear polymorphic cells with often severe fibrosis progression resulting in a loss of function.
The biomarker, though not specific, is a polyclonal elevated serum IgG4, and histological marker, currently held by several teams, is the presence within the inflammatory infiltrate, of a predominance of IgG4-expressing plasma-cells with a relative plasma-cells IgG4 + / IgG +> 50% on tissue immunostaining.
The investigators project provides a global assessment of T lymphocyte abnormalities and specifically the TFH (Follicular Helper) during this IgG4-related disease compared to so-called groups "control" subjects suffering from Sjogren syndrome or healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG4-related Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IgG4-related disease
Arm Type
Experimental
Arm Description
Subjects suffering from IgG4-related disease
Arm Title
Sjögren syndrome
Arm Type
Active Comparator
Arm Description
Subjects suffering from Sjôgren syndrome
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
Healthy subjects
Intervention Type
Biological
Intervention Name(s)
extra blood draw samples
Primary Outcome Measure Information:
Title
Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood
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:
IgG4-related disease patients or
Sjogren syndrome patients or
Healthy subjects
Exclusion Criteria:
Presence of autoimmune or inflammatory associated disease
Age less than 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle Desalbres
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
APHM
City
Marseille
ZIP/Postal Code
13
Country
France
12. IPD Sharing Statement
Learn more about this trial
Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease
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