Quantitative and Functional Study of TH17 Lymphocytes in Horton's Disease (HD)

NCT02065297 | Completed

• 1 other identifier: AUDIA-SAMSON HORTON TH17
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this open, controlled, multicentre biomedical research study is to identify new markers specifically associated with Horton's disease. This would make it possible to improve the diagnosis and management of this disease. Participation consists in taking one or several blood samples depending on the group patients/controls.

Conditions

Horton's Disease; Infectious Disease; Neoplasia; Solid Tumor; Hemopathy

Outcome Measures

Primary Outcomes (4)

• Quantification of specific cytokines of the Th17 immune response (IL-17 A and IL-23) in the serum

  Up to 6 months

• Quantification of LTh17 by flow cytometry

  Up to 6 months

• Measurement of the activation level of genes specifically involved in Th17 response using RT-PCR on frozen mRNA

  Up to 6 months

• Measure the ability of Treg to proliferate and to synthesize IL-17 in response to different antigenic stimulations

  Up to 6 months

Study Arms (4)

Horton's disease

Other: 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)

Infectious disease

Other: 1 blood sample

Neoplasia

Other: 1 blood sample

Control

Other: 1 blood sample

Interventions

1 blood sample OTHER

Control; Infectious disease; Neoplasia

2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse) OTHER

Horton's disease

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Horton' s disease Patients with an infectious disease Patients with neoplasia ( solid tumor or hemopathy ) Healthy controls

You may qualify if:

• Patients
• Patients who have provided written informed consent
• Patients with national health insurance cover
• Age: 50 to 90 years
• Patients with Horton' s disease :
• at the diagnosis, before any treatment
• or in remission
• or in relapse
• Patients with an infectious disease :
• Bacteriologically or radiologically confirmed
• Presenting an inflammatory syndrome defined by :
• CRP ≥ 10 mg / L
• and Fibrinogen ≥ 4 g / L or ESR ≥ 30 mm at H1
• Patients with neoplasia ( solid tumour or hemopathy ) :
• At the diagnosis, before treatment by chemotherapy

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (3)

CHU de BESANCON

Besançon, 25000, France

Location

CHU de DIJON

Dijon, 21079, France

Location

CH de METZ

Metz, 57000, France

Location

MeSH Terms

Conditions

Giant Cell Arteritis; Communicable Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 19, 2014
• Study Start: July 28, 2009
• Primary Completion: January 7, 2016
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

FR (3)