Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease (G4-FH)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: IgG4-related Disease

Treatments: Biological: extra blood draw samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02899039

2011-31 (Other Identifier)

RC12_3608 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

IgG4-related disease

Experimental group

Description:

Subjects suffering from IgG4-related disease

Treatment:

Biological: extra blood draw samples

Sjögren syndrome

Active Comparator group

Description:

Subjects suffering from Sjôgren syndrome

Treatment:

Biological: extra blood draw samples

Healthy controls

Active Comparator group

Description:

Healthy subjects

Treatment:

Biological: extra blood draw samples