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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
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for IgG4-related Disease

Eligibility Criteria

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

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

First Posted
September 2, 2016
Last Updated
July 27, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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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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