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

NCT ID: NCT02899039

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-17

Study Completion Date

2016-05-07

Brief Summary

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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

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Conditions

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IgG4-related Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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IgG4-related disease

Subjects suffering from IgG4-related disease

Group Type EXPERIMENTAL

extra blood draw samples

Intervention Type BIOLOGICAL

Sjögren syndrome

Subjects suffering from Sjôgren syndrome

Group Type ACTIVE_COMPARATOR

extra blood draw samples

Intervention Type BIOLOGICAL

Healthy controls

Healthy subjects

Group Type ACTIVE_COMPARATOR

extra blood draw samples

Intervention Type BIOLOGICAL

Interventions

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extra blood draw samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urielle Desalbres

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

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APHM

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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RC12_3608

Identifier Type: REGISTRY

Identifier Source: secondary_id

2011-31

Identifier Type: -

Identifier Source: org_study_id

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