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

IgG4-related Disease Clinical Trial

— G4-FH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899039
• Other study ID #: 2011-31
• Secondary ID: RC12_3608
• Status: Completed
• Phase: N/A
• Start date: July 17, 2012
• Est. completion date: May 7, 2016

Study information

• Verified date: September 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 7, 2016
• Est. primary completion date: May 4, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• IgG4-related Disease

Intervention

Biological:
• extra blood draw samples

Locations

Country	Name	City	State
France	APHM	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood		36 months