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OpenTrials
Completed

NCT Number: NCT02899039

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

APHM

Marseille, 13, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extra blood draw samples

Biological

Primary outcomes

  1. Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: G4-FH

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Sep 13, 2016
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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