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

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.

Study Overview

• Status: Completed
• Conditions: Infectious Disease; Solid Tumor; Hemopathy; Horton's Disease; Neoplasia
• Intervention / Treatment: Other: 2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse); Other: 1 blood sample

• Study Type: Observational
• Enrollment (Actual): 143

Contacts and Locations

Study Locations

• France
  • Besancon, France, 25000
    • CHU de Besançon
  • Dijon, France, 21079
    • CHU de Dijon
  • Metz, France, 57000
    • CH de METZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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
• Presenting an inflammatory syndrome defined by:
• CRP ≥ 10 mg / L
• and Fibrinogen ≥ 4 g / L or ESR ≥ 30 mm at H1

Controls :

These are healthy volunteers recruited among blood donators at Dijon CHU, voluntary hospital personnel ( nurses, doctors and secretaries ), patients at the EPHAD ( Champmaillot centre for geriatric patients ) and patients without infectious, inflammatory, or auto-immune disease ( CRP < 5mg / L ) or cancer recruited from the investigating departments of Dijon CHU. They will be matched for age and sex.

• Age: 18 - 90 years
• Patients with national health insurance cover
• who have provided written informed consent
• Absence of an inflammatory syndrome ( CRP < 5 mg / L )

Exclusion Criteria :

• Any patient who does not meet the inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control	Other: 1 blood sample
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2009
• Primary Completion (Actual): January 7, 2016

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Disease Attributes; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Arteritis; Infections; Communicable Diseases; Polymyalgia Rheumatica; Giant Cell Arteritis
• Other Study ID Numbers: AUDIA-SAMSON HORTON TH17