Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease

Not Applicable

Completed

• Conditions: IgG4-related Disease
• Interventions: Biological: extra blood draw samples

• Registration Number: NCT02899039
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-17
• Primary Completion: 2015-05-04
• Study Completion: 2016-05-07
• Status Verified: 2016-09
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-13
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	extra blood draw samples	Healthy subjects
IgG4-related disease	extra blood draw samples	Subjects suffering from IgG4-related disease
Sjögren syndrome	extra blood draw samples	Subjects suffering from Sjôgren syndrome

Primary Outcome Measures

Name	Time	Method
Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood	36 months

Trial Locations

Locations (1)

APHM; 🇫🇷 Marseille, France