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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02899039
Acronym
G4-FH
Enrollment
75
Registered
2016-09-13
Start date
2012-07-17
Completion date
2016-05-07
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgG4-related Disease

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.

Interventions

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood36 months

Countries

France

Contacts

STUDY_DIRECTORUrielle Desalbres

Assistance Publique Hôpitaux de Marseille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026