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

Completed

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

• Registration Number: NCT02065297
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-28
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-19
• Primary Completion: 2016-01-07
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoplasia	1 blood sample	-
Control	1 blood sample	-
Horton's disease	2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)	-
Infectious disease	1 blood sample	-

Primary Outcome Measures

Name	Time	Method
Quantification of LTh17 by flow cytometry	Up to 6 months
Quantification of specific cytokines of the Th17 immune response (IL-17 A and IL-23) in the serum	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

Trial Locations

Locations (3)

CHU de BESANCON; 🇫🇷 Besancon, France

CH de METZ; 🇫🇷 Metz, France

CHU de DIJON; 🇫🇷 Dijon, France